FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT TEST DRUM
MDR report key: 4609988
·
Received March 17, 2015
Report
- Report Number
- 1823260-2015-02081
- Event Type
- Malfunction
- Date Received
- March 17, 2015
- Date of Event
- February 17, 2015
- Report Date
- May 7, 2015
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K031755
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY DRUM WAS RETURNED.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES ON (B)(6) 2015: 39 MG/DL, 29 MG/DL AND 109 MG/DL, AND ON (B)(6) 2015 29 MG/DL AND 141 MG/DL. VIAL HAS BEEN DISCARDED. NO DEATH OR SERIOUS INJURY REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179766 | ACCU-CHEK ® COMPACT TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 208101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 078 YR | PIOGLITAZONE| LEVEMIR| SIMVASTATIN| LISINOPRIL| METFORMIN| GLIPIZIDE |