Reported Reactions

Devices › Syringe, piston

Device brand name · Reservoir

Rsvr Prdgm: medical device reports filed with FDA

563 reports name it, 2004–2007. Manufacturer given most often on reports: Medtronic Minimed. Product code FMF.

563
device reports naming the brand
0% of all MAUDE reports · about 25 a year
0
reports, 12 months to August 2026
0 in the 12 months before
96.3%
classified as malfunction
88.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 563 reports that name the brand "Rsvr Prdgm" (reservoir), received between April 2004 and February 2007; the manufacturer given most often on reports is Medtronic Minimed. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (96.3%) and injury (3.6%); across all syringe, piston reports (product code FMF) death is recorded in 0.1% and malfunction in 88.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are leak/splash (48.8%), fluid/blood leak (38.5%) and bubble(s) (5.3%). The patient problems coded most often are blood glucose, high, elevated ketones/ diabetic ketoacidosis and hospitalization required. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

No report naming Rsvr Prdgm was received in the five years to August 2026; the latest was received in February 2007.

By year received

01172332004: 8920042005: 16320052006: 23320062007: 782007

Event type and report source

Event type, as classified on the report

Death0%0
Injury3.6%20
Malfunction96.3%542
Other0%0
Not given0.2%1

Who filed the report

Manufacturer report100%563
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 53,081 reports carrying product code FMF. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Leak/splashthe device leaked27548.8%18%
Fluid/blood leak21738.5%6%
Bubble(s)305.3%0.1%
Replace173%0.3%
Other (for use when an appropriate device code cannot be identified)91.6%0.2%
Failure to deliverthe device did not deliver the dose or item81.4%3.6%
Moisture damage81.4%0.1%
Reservoir71.2%0%
Component missing61.1%0.6%
Device emits odor61.1%0.1%
Loose61.1%0.1%
Repair61.1%0%
Alarm, audible50.9%0.1%
Bent50.9%0.4%
Component(s), broken50.9%0.6%
Crackthe device cracked40.7%2.6%
Device alarm system40.7%0.1%
Detachment of device component30.5%1.1%
Difficult to removethe device was hard to remove30.5%0.2%
Dislodged30.5%0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Blood glucose, high8615.3%
Elevated ketones/ diabetic ketoacidosis162.8%
Hospitalization required152.7%
Hyperglycemiahigh blood sugar91.6%
Treatment with medication(s)61.1%
No patient involvement40.7%
Blood glucose, low20.4%
Vomitingbeing sick20.4%
Blood pressure, high10.2%
Other (for use when an appropriate patient code cannot be identified)10.2%
Overmedicated10.2%
Reactiona reaction, type not specified10.2%
Renal failurekidney failure10.2%
Therapy/non-surgical treatment, aborted/stopped10.2%
Therapy/non-surgical treatment, additional10.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureRsvr PrdgmProduct code FMFAll MAUDE reports
Reports56353,08126,136,888
Share of that pool—1.1%0%
Classified as death, per 1,000 reports019
Classified as injury3.6%9.9%36.2%
Classified as malfunction96.3%88.5%62.3%
Filed by the manufacturer100%93.7%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code FMF

BrandReportsLatest 12 monthsClassified as death
Inpen Mmt-105nnblna Novo Nordisk Blue1,6201880.1%
Inpen Mmt-105elblna Eli Lily Blue1,2921680.1%
Inpen Mmt-105nnpkna Novo Nordisk Pink1,1422190.1%
Rsvr Mmt-326a 10pk Prdgm 1 8ml 13l1,10300.4%
Kit MMT-105NNBLW1 NovoNordisk Blue OUS11,0116550%
BD Luer-Lok1,0013330%
Inpen Mmt-105nngyna Novo Nordisk Gray9721430%
Unspecified Bd Syringe92600.1%
Bd Insulin Syringe With The Bd Ultra-Fine Needle86900%
Bd Ultra-Fine Insulin Syringe84900%
Inpen Mmt-105elpkna Eli Lily Pink8051230%
Inpen Mmt-105elgyna Eli Lily Gray736880%
Bd Luer-Lok Tip Syringe62400%
Bd Luer-Lok Syringe59500%
Novopen 4567670.7%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Rsvr Prdgm reports

How many FDA reports name Rsvr Prdgm?

563 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (96.3%) and injury (3.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

leak/splash (48.8%), fluid/blood leak (38.5%), bubble(s) (5.3%), replace (3%) and other (for use when an appropriate device code cannot be identified) (1.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Rsvr Prdgm was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.