FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MOBILE TEST STRIPS
MDR report key: 1802541
·
Received August 17, 2010
Report
- Report Number
- 1823260-2010-04876
- Event Type
- Malfunction
- Date Received
- August 17, 2010
- Date of Event
- August 10, 2010
- Report Date
- August 27, 2010
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
THE HARMONIC ACE WOULD NOT RECOGNIZE INSTRUMENTS IN THE TEST PHASE.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED RESULTS OF 329 MG/DL AND 85 MG/DL WITHIN 10 MINUTES ON THE MOBILE SYSTEM. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS; CUSTOMER WAS ABLE TO SELF TREAT AND LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® MOBILE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 277056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 025 YR | HUMALOG |