FDA Adverse Event Malfunction Summary report: N

ACCU-CHEK ® SPIRIT COMBO

MDR report key: 3093346 · Received May 6, 2013

Report

Report Number: 2183996-2013-00787
Event Type: Malfunction
Date Received: May 6, 2013
Date of Event: April 22, 2013
Report Date: June 12, 2013
Manufacturer: ROCHE DIABETES CARE AG
Product Code: LZG
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: PATIENT

Narratives

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.

Additional Manufacturer Narrative · 1

THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE ALARM FUNCTIONS OF THE PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS.

Description of Event or Problem · 1

PATIENT EXPERIENCED LOW BLOOD GLUCOSE LEVELS OF 1.8 MMOL/L (32.4 MG/DL) ON (B)(6) 2013 AND 2.2 MMOL/L (39.6 MG/DL) ON (B)(6) 2013, AND SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. SHE SWITCHED TO A LOANER INFUSION DEVICE AND HAS NOT EXPERIENCED FURTHER CONCERNS. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
196126	ACCU-CHEK ® SPIRIT COMBO	INSULIN INFUSION PUMP	LZG	ROCHE DIABETES CARE AG	00700006863	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	034 YR