FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK ® COMPACT TEST DRUM
MDR report key: 1950885
·
Received January 6, 2011
Report
- Report Number
- 1823260-2011-00071
- Event Type
- Injury
- Date Received
- January 6, 2011
- Date of Event
- December 14, 2010
- Report Date
- February 28, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CALLER REPORTED CUSTOMER HAD NOT EATEN SUPPER, TESTED AT HOME AND GOT A COMPACT PLUS RESULT OF 15.7 MMOL/L. WITHIN A FEW MOMENTS, THE CUSTOMER PASSED OUT. CUSTOMER WIFE CALLED 911, AMBULANCE CAME AND TESTED THE CUSTOMER AT "2.? MMOL/L", NO TIME FRAME PROVIDED. THE CUSTOMER WAS HOSPITALIZED, TREATED WITH IV FLUIDS. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.
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 | 20726346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 042 YR | Hospitalization | METOPROLOL| "EZETECOA"| ASA| ALTACE| METFORMIN 3XDAY| NITROPATCH| CRESTOR| HUMULIN| NITROSPRAY| PARIET |