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 2017-10-17 for D-DIMER 04912551190 manufactured by Roche Diagnostics.
[90556919]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90556920]
The customer stated that they received erroneous results for one patient sample tested for d-di tina-quant d-dimer gen. 2 (d-dimer) on a cobas integra 400 plus (i400+). The erroneous results were reported outside of the laboratory. On (b)(6) 2017, the patient had a d-dimer result of 2755 ng/ml. On (b)(6) -2017, the patient had a d-dimer result of 2592 ng/ml. On (b)(6) -2017, the patient had a d-dimer result of 2565 ng/ml. On (b)(6) -2017, the patient had a d-dimer result of 2148 ng/ml. The complained sample was initially tested on an acl analyzer on (b)(6) 2017, resulting with a d-dimer value of 0. 23 ug/ml. An aliquot from the same sample was tested on the i400+ on (b)(6) 2017, resulting as 2020 ng/ml. A second aliquot from the same sample was tested on a second i400+ in a second laboratory, resulting as 2029 ng/ml. A third aliquot from the same sample was tested on a star evolution analyzer, resulting as 320 ng/ml. On (b)(6) 2017, a second sample was collected from the patient and measured twice on the i400+ analyzer, resulting as 2132 ng/ml and 2157 ng/ml. This sample had an igg result of 10. 98 g/l and an igm result of 5. 44 g/l. No adverse events were alleged to have occurred with the patient. The i400+ analyzer used at the customer site was 402443. The serial number of the i400+ analyzer used the second site was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02336 |
| MDR Report Key | 6954042 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-17 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-10-01 |
| Date Mfgr Received | 2017-10-01 |
| Date Added to Maude | 2017-10-17 |
| 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 | 2017-10-17 |
| Model Number | NA |
| Catalog Number | 04912551190 |
| Lot Number | 23293201 |
| ID Number | NA |
| Device Expiration Date | 2018-03-31 |
| 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 | 2017-10-17 |