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 2018-07-13 for D-DIMER 04912551190 manufactured by Roche Diagnostics.
[114154108]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[114154109]
The customer complained of high results for 1 patient tested for d-di2 tina-quant d-dimer gen. 2 (d-di2) on a cobas integra 400 plus. On (b)(6) 2018 the patient was initially tested on the integra 400 plus instrument with a result of 1423 ng/ml. A new sample was obtained on (b)(6) 2018 and the result from the integra 400 plus was 1440 ng/ml. The patient was tested 1 week prior to the event on a coagulogic analyzer and the d-dimer result was < 500 ng/ml. The result of < 500 ng/ml better corresponds to the patient's clinical condition. On (b)(6) 2018 the sample from (b)(6) 2018 was tested on an acl analyzer top 500 instrument and the result was 367 ng/ml. This same sample was also run in another laboratory using an acl analyzer top 300 instrument and the result was 194 ng/ml. The result of 1440 ng/ml was reported outside of the laboratory. There was no allegation that an adverse event occurred. The integra 400 plus serial number was (b)(4). The field service engineer (fse) visited the customer site on 28-jun-2018 to perform regular preventive maintenance and no technical problems were found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02308 |
| MDR Report Key | 7685046 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-13 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-06-22 |
| Date Mfgr Received | 2018-06-28 |
| Date Added to Maude | 2018-07-13 |
| 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 | 2018-07-13 |
| Model Number | NA |
| Catalog Number | 04912551190 |
| Lot Number | 32475701 |
| Device Expiration Date | 2019-05-31 |
| 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 | 2018-07-13 |