FDA Adverse Event
Malfunction
Summary report: N
ROCHE CARDIAC D-DIMER
MDR report key: 5039385
·
Received August 28, 2015
Report
- Report Number
- 1823260-2015-04045
- Event Type
- Malfunction
- Date Received
- August 28, 2015
- Date of Event
- August 11, 2015
- Report Date
- September 16, 2015
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GHH
- PMA / PMN Number
- K033491
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR ROCHE CARDIAC D-DIMER ON THE H232 INSTRUMENT USED IN A CLINIC. THE DATE OF EVENT WAS NOT PROVIDED. THE INITIAL ROCHE CARDIAC D-DIMER RESULT ON THE H232 INSTRUMENT WAS 3.2 UG/ML. THE RESULT FROM AN OUTSOURCED SITE OBTAINED ON AN NS AUTO-DIMER INSTRUMENT WAS 47.4 UG/ML. NO ADVERSE EVENT OCCURRED. THE H232 INSTRUMENT SERIAL NUMBER WAS NOT PROVIDED. NEITHER THE H232 INSTRUMENT NOR A SIMILAR DEVICE IS SOLD IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572340 | ROCHE CARDIAC D-DIMER | FIBRIN SPLIT PRODUCTS | GHH | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |