ACCU-CHEK ® SPIRIT COMBO

Report

Report Number: 2183996-2013-01425
Event Type: Malfunction
Date Received: July 30, 2013
Date of Event: July 22, 2013
Report Date: October 30, 2013
Manufacturer: ROCHE HEALTH SOLUTIONS, INC.
Product Code: LZG
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE SOFT COMPONENT OF THE UP AND DOWN BUTTON IS DAMAGED DUE TO HANDLING WITH SHARP OBJECTS. THE BUTTONS SHOULDN'T BE ACTUATED BY USING HARD OR SHARP OBJECTS. DUE TO THE LEAKY SOFT COMPONENTS, LIQUID ENTERED THE PUMP ELECTRONICS AND ALL BUTTONS ARE WITHOUT FUNCTION.

Additional Manufacturer Narrative · 1

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

PATIENT REPORTED THE INFUSION DEVICE SELECTED A "QUICK BOLUS" AUTOMATICALLY ON (B)(6) 2013, AND SHE WAS UNABLE TO STOP THE BOLUS DELIVERY AS THE BUTTONS WOULD NOT FUNCTION. SHE REMOVED AND REINSERTED THE BATTERY, BUT THIS DID NOT RESOLVE THE ISSUE. SHE REPORTED THE INFUSION DEVICE WAS "DEAD." SHE INSERTED THE BATTERY AGAIN ON (B)(6) 2013, AND THE INFUSION DEVICE STARTED AS NORMAL. THE PROTECTIVE RUBBER IS WORN OUT, AND THE INFUSION DEVICE WAS EXPOSED TO WATER LAST YEAR. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
356363	ACCU-CHEK ® SPIRIT COMBO	INSULIN INFUSION PUMP	LZG	ROCHE HEALTH SOLUTIONS, INC.	00700006863	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	036 YR