FDA Adverse Event
Malfunction
Summary report: N
ROCHE CARDIAC D-DIMER
MDR report key: 4936084
·
Received July 23, 2015
Report
- Report Number
- 1823260-2015-03852
- Event Type
- Malfunction
- Date Received
- July 23, 2015
- Date of Event
- July 8, 2015
- Report Date
- August 4, 2015
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GHH
- PMA / PMN Number
- K033491
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- 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.
Description of Event or Problem · 1
THE CUSTOMER RECEIVED A QUESTIONABLE D-DIMER RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS H232 METER SERIAL NUMBER (B)(4). THE METER IS NOT SOLD IN THE UNITED STATES. THE INITIAL RESULT WAS 2.40 UG/ML AND WAS REPORTED OUT. THE PATIENT WAS SENT TO HOSPITAL AND APPROXIMATELY TWO HOURS LATER A RESULT OF 1.2 UG/ML WAS RECEIVED FROM AN UNKNOWN ANALYZER. THE PATIENT WAS NOT ADVERSELY AFFECTED. RELEVANT RETENTION MATERIAL WAS TESTED AND THE RESULTS FULFILLED THE REQUIREMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 478577 | ROCHE CARDIAC D-DIMER | FIBRIN SPLIT PRODUCTS | GHH | ROCHE DIAGNOSTICS | NA | 28217110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |