FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMPACT TEST DRUM
MDR report key: 1211362
·
Received October 22, 2008
Report
- Report Number
- 1823260-2008-07791
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- October 9, 2008
- Report Date
- October 22, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K031755
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACCU-CHEK COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 410MG/DL, 216MG/DL, 198MG/DL AND 196MG/DL. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECTED PRODUCT; REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMPACT TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | "TRANTOL"| "ADVODART"| "TALEVO"| POTASSIUM CHLORIDE| MIRAPEX| "DYTROPLAN XL"| FLOMAX| NEURONTIN| "BENCEPHIL"| SPIRONOLACTONE| LASIX| COUMADIN - 6 MONTHS| LIPITOR| "NIASIN"| AMITRIPTYLINE| ALLEGRA D| INSULIN NPH (UNK TYPE)| COREG| HUMULIN R |