ACCU-CHEK AVIVA TEST STRIPS

Report

• Report Number: 1823260-2008-08214
• Event Type: Injury
• Date Received: November 6, 2008
• Date of Event: October 10, 2008
• Report Date: November 6, 2008
• Manufacturer: ROCHE DIAGNOSTICS
• Product Code: LFR
• PMA / PMN Number: K043474
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: CA, US
• Reporter Occupation: LAY USER/PATIENT

Narratives

Description of Event or Problem · 1

CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF '190S' MG/DL ON THE AVIVA SYSTEM. HE TOOK HIS NORMAL 50 UNITS OF LANTUS INSULIN AND 500 MG OF METFORMIN. STATES 15-20 MINUTES LATER HE FELT DIZZY, AND A SHARP PAIN IN HIS HEAD AND BLACKED OUT. HE STATES HE FELL AND HIT HIS HEAD. HE STATES HIS SON CALLED THE EMT'S WHO TESTED HIS BLOOD GLUCOSE AND BECAUSE IT WAS LOW (EXACT VALUE NOT PROVIDED), THEY GAVE HIM "AN INJECTION OF GLUCOSE WATER". HE ALSO REPORTED STORING THE STRIPS OUTSIDE OF THEIR ORIGINAL VIAL, PUTTING THEM IN HIS MEDICATION BOTTLE, WHICH IS AGAINST MANUFACTURER'S LABELING. IMPROPERLY STORED PRODUCT MAY PRODUCE ERRONEOUS RESULTS. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM AND A REPLACEMENT WAS SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK AVIVA TEST STRIPS	BLOOD GLUCOSE MONITORING TEST STRIPS - LFR	LFR	ROCHE DIAGNOSTICS

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Required Intervention	HYDROCODONE 500 MG/DAY - 8 YEARS| LANTUS 50 UNITS/DAY - 8 YEARS| METFORMIN 1000 MG/DAY - 2-3 YEARS| BENAZEPRIL 20 MG/DAY - 1 YEAR| AMLODIPINE BESTYLATE 5 MG/DY - 3-4 MONTHS| FUROSEMIDE 20 MG/DAY - 2-3 MONTHS| METOPROLOL 25 MG/DAY - 3 MONTHS

Terms

Patient problem · 1

• Hypoglycemia

Product problems · 1

• Use of Device Problem

Source type · 1

• Consumer

Type of report · 1

• Initial submission