FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT TEST DRUM
MDR report key: 3102837
·
Received May 9, 2013
Report
- Report Number
- 1823260-2013-02841
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 9, 2013
- Report Date
- May 9, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K031755
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. ABSENT THE DEVICE LOT NUMBER, MANUFACTURE DATE CANNOT BE DETERMINED. STRIPS NOT AVAILABLE FOR RETURN.
Description of Event or Problem · 1
CALLER REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULTS OF 419 MG/DL, 294 MG/DL, AND 120 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS. STRIPS ARE NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203254 | ACCU-CHEK ® COMPACT TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 057 YR | CATAPRES 2X DAILY| WALKER| AIR CONCENTRATOR| IBUPROFEN| NORCO 10 325| OXYGEN| TRAPEZE FOR GETTING IN/OUT BED| LASIX| POTASSIUM CHLORIDE| LEXAPRO| HUMALOG| LANTUS| CALCIUM TABLETS| LORATADINE| TRILEPTAL| ATENOLOL 2X DAILY| WHEEL CHAIR| PROMETHAZINE 1-2X DAILY| ZANTAC| NEURONTIN |