FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT TEST DRUM
MDR report key: 2033577
·
Received March 30, 2011
Report
- Report Number
- 1823260-2011-01700
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- March 14, 2011
- Report Date
- April 25, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K031755
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED RESULT OF 333 MG/DL AND RESULT OF 150 - 155 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 | ROCHE DIAGNOSTICS | NA | 20729244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 067 YR | BUMETANIDE| CELEBREX| DIABETES VITAMIN PACK| ZOLPIDEM| ASPIRIN| CPAP MACHINE| ZYRTEC| OXYCONTIN| SYNTHROID| AMITRIPTYLINE| EPLERENONE| CARVEDILOL| NOVOLOG| SYMLIN| UNKNOWN INSULIN PUMP| "MEDTRONIC" GLUCOSE METER |