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 2018-04-13 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[106039615]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[106039616]
The customer complained of discrepant results for 1 patient sample tested for roche cardiac d-dimer between two h232 instruments. The initial d-dimer result from a venous sample on h232 instrument serial number (b)(4) was 0. 6 (unit of measure not provided). "almost simultaneously," the sample was repeated on a second h232 instrument and the result was 1. 5. The internal qc failed on h232 instrument with serial number (b)(4) so the customer thinks the result of 0. 6 is incorrect. The internal qc for the second h232 instrument passed. The patient was not adversely affected. The cobas h232 instrument nor a similar device is approved for distribution in the united states. The instrument and test strips were requested for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01152 |
| MDR Report Key | 7429223 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-13 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-04-02 |
| Date Mfgr Received | 2018-04-02 |
| Date Added to Maude | 2018-04-13 |
| 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 |
| 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 | 2018-04-13 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 25712711 |
| ID Number | NA |
| 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 | 2018-04-13 |