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 2018-11-19 for D-DIMER 04912551190 manufactured by Roche Diagnostics.
[129197909]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[129197910]
The customer stated that they received questionable results for three patient samples tested with d-di tina-quant d-dimer gen. 2 on a cobas 8000 c 502 module. The customer stated that the samples will initially be slightly below the technical limit of the assay, but when repeated with decreased sample volume, the results are much higher. The customer provided data for one of the affected patient samples and this sample had an erroneous d-di value. The erroneous result was not reported outside of the laboratory. The sample initially resulted with a value of 7704 ug/l. The sample was repeated using a decreased sample volume, resulting as 14857 ug/l. The sample was manually diluted x 2 and tested, resulting as 13322 ug/l. The sample was manually diluted x 3 and tested, resulting as 15657 ug/l. The sample was manually diluted x 4 and tested, resulting as 16474 ug/l. The sample was manually diluted x 5 and tested, resulting as 17300 ug/l. The sample was manually diluted x 6 and tested, resulting as 17322 ug/l. The sample was repeated on a siemens cs2500 module, resulting as 14148 ug/l. The sample was repeated on the c 502 analyzer on (b)(6) 2018, resulting as 7792 ug/l. The sample was repeated on the c 502 analyzer on (b)(6) 2018 using a decreased sample volume, resulting as 13991 ug/l. No adverse events were alleged to have occurred with the patient. The c502 analyzer serial number is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04376 |
| MDR Report Key | 8085292 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-19 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-10-23 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-11-19 |
| 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 | D-DIMER |
| Generic Name | FIBRIN SPLIT PRODUCTS |
| Product Code | GHH |
| Date Received | 2018-11-19 |
| Model Number | NA |
| Catalog Number | 04912551190 |
| Lot Number | 343317 |
| 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 | 2018-11-19 |