FDA Adverse Event Malfunction Summary report: N

ACCU-CHEK SPIRIT COMBO

MDR report key: 2833406 · Received October 26, 2012

Report

Report Number: 2183996-2012-01649
Event Type: Malfunction
Date Received: October 26, 2012
Date of Event: October 22, 2012
Report Date: October 22, 2012
Manufacturer: ROCHE INSULIN DELIVERY SYSTEMS, INC.
Product Code: LZG
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

PT REPORTED THE DISPLAY ON THE INFUSION DEVICE HAS A BLACK SPOT ON THE DISPLAY. PT STATED MISINTERPRETATION OF THE VALUES IS POSSIBLE. PT REPORTED ON (B)(6) 2012 HE NOTICED THE INFUSION DEVICE DISPLAY HAD A BLACK SPOT ON IT. PT STATED HIS BLOOD GLUCOSE LEVEL WAS 86 MG/DL BETWEEN 7:30 PM AND 8 PM. PT REPORTED HE ATE AND ADMINISTERED 8.0 UNITS OF INSULIN VIA THE INFUSION DEVICE AND THEN AT 11 PM, HIS BLOOD GLUCOSE LEVEL WAS 96 MG/DL. PT STATED ON (B)(6) 2012 AT 1 AM, HIS BLOOD GLUCOSE LEVEL WAS 41 MG/DL AND HE ATE. PT REPORTED HE THINKS THAT HE INTERPRETED THE BOLUS WRONG THEREFORE HE HAD HYPOGLYCEMIA. PT STATED HE WAS ABLE TO GET HIS BLOOD GLUCOSE LEVEL UNDER CONTROL BY HIMSELF. PT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFO IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK SPIRIT COMBO		LZG	ROCHE INSULIN DELIVERY SYSTEMS, INC.	00700006863	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR			INSULIN INFUSION PUMP\| INSULIN\| RELATED ACCESSORIES