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 2017-09-26 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[89504622]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[89504623]
The customer received questionable d-dimer results for five patient samples from a cobas h232 meter serial number (b)(4) on (b)(6) 2017 when compared to the results previously obtained from a mini vidas analyzer. The cobas h232 meter is not sold nor is like or similar to a product sold in the united states. It was unclear if the same samples were used for the testing on the different devices. Clarification was requested but was not provided. Sample 1: the result from the mini vidas on (b)(6) 2017 was 198. 93 ng/ml. The result from the h232 meter was 180. 00 ng/ml. Sample 2: the result from the mini vidas on (b)(6)2017 was 2119. 51 ng/ml. The result from the h232 meter was 490. 0 ng/ml. Sample 3: the result from the mini vidas on (b)(6) 2017 was 853. 30 ng/ml. The result from the h232 meter was 550. 00 ng/ml. Sample 4: the result from the mini vidas on (b)(6) 2017 was 1130. 25 ng/ml. The result from the h232 meter was 680 ng/ml. Sample 5: the result from the mini vidas on (b)(6) 2017 was 324. 98 ng/ml. The result from the h232 meter was 280. 0 ng/ml. The erroneous results were not reported outside of the laboratory. The patients were not adversely affected. No customer material was received for investigation. Relevant retention material of roche cardiac d-dimer of lot 19752510 was tested on a qualified cobas h232 with: two native blood samples and two spiked blood samples (c=0. 80? G/ml and c=1. 10? G/ml), each blood sample was tested with three test strips. The mean of the measurements on a qualified cobas h232: first native blood sample: 0. 17 ug/ml. Second native blood sample: 0. 29 ug/ml. First spiked blood sample (c=0. 80? G/ml): 0. 76 ug/ml. Second spiked blood sample (c=1. 10? G/ml): 0. 99 ug/ml. The results of all measurements fulfill the requirements.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02088 |
| MDR Report Key | 6893088 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-26 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2017-09-01 |
| Date Added to Maude | 2017-09-26 |
| 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 | 2017-09-26 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 19752510 |
| ID Number | NA |
| Device Expiration Date | 2017-11-01 |
| 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 | 2017-09-26 |