FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MOBILE TEST STRIPS
MDR report key: 2081770
·
Received May 9, 2011
Report
- Report Number
- 1823260-2011-02463
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 31, 2011
- 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). CALLER DID NOT HAVE PRODUCT INFORMATION FOR THE COMPACT PLUS SYSTEM. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). CALLER DID NOT HAVE PRODUCT INFORMATION FOR THE COMPACT PLUS SYSTEM.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED RESULT OF 226 MG/DL ON THE MOBILE SYSTEM AND 40 MG/DL ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER WAS TREATED WITH DEXTROSE. 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 | 278021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 083 YR | "ASS"| ATMADISC FORTE SPRAY| ATEHEXAL| "THEOPHYLLIN RETARD"| "MORPHIUM"| MOLSIDOMINE| TORSEMIDE| NITRENDIPINE| IBUPROFEN |