FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1011470
·
Received March 11, 2008
Report
- Report Number
- 1823260-2008-02291
- Event Type
- Injury
- Date Received
- March 11, 2008
- Date of Event
- February 14, 2008
- Report Date
- March 11, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED CUSTOMER OBTAINED A BLOOD GLUCOSE VALUE OF 91 MG/DL WHILE EXPERIENCING LOW BLOOD GLUCOSE SYMPTOMS. REPORTER STATED CUSTOMER WAS GIVEN ORANGE JUICE AND EMTS WERE SUMMONED. EMTS WERE REPORTED TO HAVE ARRIVED 15 MINS LATER, AT WHICH TIME A BLOOD GLUCOSE VALUE OF 51 MG/DL WAS OBTAINED ON A PROFESSIONAL METER; OXYGEN WAS ADMINISTERED AND THE CUSTOMER WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS TREATED WITH AN IV OF UNK CONTENTS AND FOOD. THE CUSTOMER WAS RELEASED THE SAME DAY. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS | 550087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Hospitalization| R | SULANDIAC - 2 YRS - 150MG DAILY| VITAMIN - SEVERAL YRS - DAILY| SIMVASTATIN - SEVERAL YRS - 40MG DAILY| OMEGA 3 FISH OIL - SEVERAL YRS - DAILY| METOPROLOL - SEVERAL YRS - 100MG DAILY| BENICAR HCT - SEVERAL YRS - 40-25MG DAILY| DIGITEK - SEVEAL YRS - 0.25MG DAILY| LANTUS - 2.5 YRS - 22 UNITS| APIDRA - 6 MONTHS - SLIDING SCALE| B12 - SEVERAL YRS - 2000MG DAILY| OCUVITE PRESERVISION VITAMIN SEVERAL YRS- 2 TABS D| LANTUS - 2.5 YRS - 12 UNITS| AMLOD/DENAZP - SEVERAL YRS - 5-20MG DAILY |