MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-11-28 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[129327545]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[129327546]
The customer complained of questionable roche cardiac d-dimer 10 tests (cobas) results from cobas h 232 meter serial number (b)(4). The customer provided 7 patient results of which 4 were a reportable malfunction. The cobas h232 meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states. Refer to the attachment for patient data. The units of measurements were not clear but clarification has been requested. There was no allegation of an adverse event. It was unclear if the erroneous results were reported outside of the laboratory but clarification has been requested. Liquid controls and internal qc results were acceptable. The meter and test strips have been requested for further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04503 |
| MDR Report Key | 8109751 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-28 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2018-11-07 |
| Date Added to Maude | 2018-11-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHE CARDIAC D-DIMER |
| Generic Name | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS |
| Product Code | GHH |
| Date Received | 2018-11-28 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-28 |