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 2016-06-27 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[48309057]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[48309058]
The customer stated that they received erroneous results for one patient sample tested for roche cardiac d-dimer (ddi) on a cobas h 232 analyzer. The cobas h 232 analyzer is not sold in the united states, nor is it like or similar to a product sold in the united states. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. The sample initially resulted as 0. 51 ug/ml when tested for ddi on the cobas h 232 analyzer. A second sample collected from the patient at the same time was tested on a laboratory analyzer, resulting as 2. 41 ug/ml. Both samples were repeated, with the first sample resulting with a repeat value of 0. 53 ug/ml on the cobas h232 analyzer. The second sample was repeated on the laboratory instrument, resulting as 2. 24 ug/ml. The patient was not adversely affected. The serial number of the used cobas h 232 analyzer was asked for, but not provided. The customer's cobas h 232 analyzer and ddi test strips have been requested for investigation.
Patient Sequence No: 1, Text Type: D, B5
[50325985]
It was stated that the used laboratory method was the stago liatest d-di plus method, which is an immune-turbidimetric assay.
Patient Sequence No: 1, Text Type: N, H10
[50737301]
Retention test strip and a retention cobas h 232 analyzer were tested and all test results fulfilled requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00817 |
| MDR Report Key | 5750949 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-27 |
| Date of Report | 2016-07-18 |
| Date of Event | 2016-06-14 |
| Date Mfgr Received | 2016-06-16 |
| Date Added to Maude | 2016-06-27 |
| 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 | DAP |
| Date Received | 2016-06-27 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | DD5571 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-06-27 |