ACCU-CHEK ® SPIRIT COMBO

MDR report key: 3790629 · Received May 5, 2014

Report

Report Number: 1823260-2014-03195
Event Type: Malfunction
Date Received: May 5, 2014
Date of Event: April 14, 2014
Report Date: September 17, 2014
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LZG
PMA / PMN Number: K111353
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

Description of Event or Problem · 1

ON (B)(6) 2014, THE PATIENT REPORTED THAT THE BATTERY COMPARTMENT INSIDE HER INFUSION DEVICE APPEARED BURNT AND ASHY AND THE BATTERY COVER APPEARED BLACK AND BURNT. SHE STATED THAT THE DISPLAY IS BLANK AND THE DEVICE IS BEEPING, BUT NOTHING APPEARS ON THE DISPLAY. SHE REPLACED THE BATTERY IN THE DEVICE, BUT THE SCREEN CONTINUED TO BE BLANK. SHE STATED THAT SHE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AS HIGH AS 320 MG/DL. SHE DOES NOT KNOW IF HER DEVICE IS DELIVERING INSULIN AS EXPECTED BECAUSE SHE CANNOT SEE WHAT SHOULD BE DISPLAYED. THE PATIENT THINKS THE BATTERY MAY HAVE HAD AN ELECTRICAL SHORT AND THAT COULD BE CAUSING INSULIN DELIVERY ISSUES. SHE STATED THAT THE DEVICE WAS CONSUMING BATTERIES RAPIDLY. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
269385	ACCU-CHEK ® SPIRIT COMBO	INSULIN INFUSION PUMP	LZG	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	048 YR			HUMALOG U100 70-80 UNITS PER DAY\| PRILOSEC 20MG ONCE A DAY OR MORE AS NEEDED\| HYDROCORTIZONE 30 MG PER DAY\| ABOUT 5-6 YEARS\| DONEPEZIL 5 MG ONCE A DAY\| CALCIUM 500 MG TWICE DAILY\| SIMVASTATIN 80MG ONCE A DAY\| KLOR-CON 80MG/ONCE DAILY\| VITAMIN D 50000 UNITS EVERY OTHER DAY