FDA Adverse Event Malfunction Summary report: N

RESERVOIR 1.8ML

MDR report key: 2984091 · Received February 28, 2013

Report

Report Number: 3004209178-2013-91420
Event Type: Malfunction
Date Received: February 28, 2013
Date of Event: February 25, 2013
Report Date: February 25, 2013
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: FRN
PMA / PMN Number: K001828
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

Additional Manufacturer Narrative · 1

INSPECTED ONE SEALED RESERVOIR. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIR PASSED PER INSPECTION. NO LEAKAGE ANOMALY WAS OBSERVED DURING ANALYSIS. CHECKED O-RINGS FOR DEFECTS AND NONE WERE FOUND. RESERVOIR CONNECTED AND LOCKED IN PLACE PROPERLY. INSPECTED THREE OPENED AND USED RESERVOIRS. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST. RAN PRIMING IN INSULIN PUMP. RESERVOIRS PASSED PER INSPECTION. RAN PRIMING IN INSULIN PUMP. RESERVOIRS PASSED PER INSPECTION. NO LEAKAGE ANOMALY WAS OBSERVED DURING ANALYSIS. CHECKED O-RINGS FOR DEFECTS AND NONE WERE FOUND. ALL RESERVOIRS CONNECTED AND LOCKED IN PLACE PROPERLY.

Description of Event or Problem · 1

IT WAS REPORTED THAT INSULIN FROM THE RESERVOIR LEAKED PAST THE O-RINGS AND INTO THE RESERVOIR COMPARTMENT. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
86608	RESERVOIR 1.8ML	RESERVOIR	FRN	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-326A

Patients

Seq	Age	Sex	Outcome	Treatment
1