FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMPACT TEST DRUM
MDR report key: 3082823
·
Received April 29, 2013
Report
- Report Number
- 1823260-2013-02608
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- April 14, 2013
- Report Date
- April 29, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). THE CUSTOMER IS REFUSING TO RETURN THE DEVICE. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 1 MINUTE: 4.2 MMOL/L AND 1.8 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION. THE CUSTOMER HOWEVER IS REFUSING TO RETURN THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183555 | ACCU-CHEK ® COMPACT TEST DRUM | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 070 YR |