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 2018-01-12 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[97742466]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[97742467]
The customer received questionable low cardiac d-dimer assay results for two patient sample from the cobas h232 meter serial number (b)(4). The cobas h232 meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states. On (b)(6) 2017, the result from the cobas h232 was 170 ug/l and the result from the sta analyzer was 2040 ug/l. On (b)(6) 2017, the result from the cobas h232 was 160 ug/l and the result from the sta analyzer was 2000 ug/l. Information concerning if any erroneous result was reported outside of the laboratory was requested, but it was unknown. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
[131714416]
Upon follow up with the customer, they stated the issue was not with the roche device but was with the sta analyzer.
Patient Sequence No: 1, Text Type: N, H10
[132930338]
Relevant retention material roche cardiac d-dimer of lot 22559510 was measured on qualified cobas h232 with: two native blood samples and two spiked blood samples (c=0. 80 g/ml and c=2. 2 g/ml), each blood sample n=three test strips. Mean of the measurements on qualified cobas h232: first native blood sample: 0. 20 g/ml. Second native blood sample: 0. 15 g/ml. First spiked blood sample (c=0. 80 g/ml): 0. 92 g/ml. Second spiked blood sample (c=2. 2 g/ml): 2. 00 g/ml. The results of all measurements fulfilled the requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00139 |
| MDR Report Key | 7185416 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-12 |
| Date of Report | 2018-02-19 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2018-01-03 |
| Date Added to Maude | 2018-01-12 |
| 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 | 2018-01-12 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 22559510 |
| 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 | 2018-01-12 |