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 2018-08-27 for D-DIMER 04912551190 manufactured by Roche Diagnostics.
[118558998]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[118558999]
The customer stated that they received erroneous results for five samples from the same patient tested with d-di tina-quant d-dimer on a cobas integra 400 plus (i400+ a) analyzer. The first sample was also tested on a cobas 6000 c (501) module and the second sample was tested on a second integra 400 plus analyzer (i400+ b). The erroneous results for the first two samples were reported outside of the laboratory. It was asked, but it is not known if erroneous results were reported outside of the laboratory for samples 3 - 5. According to the customer's internal process, samples are measured with different dilution ratios of 1:3, 1:6, and 1:12. Dilutions were carried out automatically by the analyzer. The customer stated that they also manually diluted the samples and results were similar to those of the automatic dilutions. No adverse events were alleged to have occurred with the patient. The serial number of the i400+ a analyzer is (b)(4). The serial number of the i400+ b analyzer is (b)(4). The serial number of the c 501 analyzer was asked for, but not provided. The issue did not occur with samples from other patients. Upon review of the calibration data, the correct target values were set. Quality controls showed good precision and accuracy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02860 |
| MDR Report Key | 7817973 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-27 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-08-27 |
| 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 | 2018-08-27 |
| Model Number | NA |
| Catalog Number | 04912551190 |
| Lot Number | 32475701 |
| 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 | 2018-08-27 |