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 2018-07-19 for D-DIMER 04912551190 manufactured by Roche Diagnostics.
[114715811]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[114715812]
The customer received questionable high d-di tina-quant d-dimer gen 2 results for one patient from the cobas 4000 c (311) system. The serial number was requested but was not provided. The initial result was 1080 ng/ml and was reported outside of the laboratory. As this was unexpectedly high, the patient went for retesting in another laboratory. The test was performed on sta compact max instrument and the result was <500 ng/ml (normal). The patient complained to the laboratory and the sample was repeated on the c311 on (b)(6) 2018 with a result of 1080 ng/ml. On (b)(6) 2018, a sample from the patient was repeated on the c311 and the result was 940 ng/ml. A sample from the patient was also tested on a siemens instrument and the result was <150 ng/ml. On (b)(6) 2018, a sample from the patient was repeated on the c311 and the result was 1170 ng/ml. On (b)(6) 2018, a sample from the patient was tested on the c311 with dilutions: with pre-dilution 1:50, the result was 480 ng/ml. With pre-dilution 1:10, the result was 900 ng/ml. With an automatic 1:24 dilution, the result was 1300 ng/ml. No treatment was based upon the high result. The patient stated that he visited an "angiologist" because of the high d-dimer result and that ultrasonic examination results were normal. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02405 |
| MDR Report Key | 7704806 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-19 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-05-14 |
| Date Mfgr Received | 2018-07-06 |
| Date Added to Maude | 2018-07-19 |
| 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 |
| 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 | 2018-07-19 |
| Model Number | NA |
| Catalog Number | 04912551190 |
| Lot Number | 278482 |
| 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 | 2018-07-19 |