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 2018-05-11 for D-DIMER 04912551190 manufactured by Roche Diagnostics.
[108381369]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4). The patient was born in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[108381370]
The customer stated that they received erroneous results for one patient sample tested for d-di tina-quant d-dimer gen. 2 (ddi) on a cobas 6000 c (501) module - c501. The erroneous results were reported outside of the laboratory to a doctor. The sample initially resulted with a ddi value of 3. 34 mg/l feu accompanied by a data flag. The sample was automatically repeated, resulting as 3. 33 mg/l feu accompanied by a data flag. The patient was sent to the hospital based on the c501 value. At the hospital, the patient was tested for ddi using sysmex analyzer which used siemens reagent. The result from the sysmex analyzer was normal, so no treatment was provided. On (b)(6) 2018, the sample was repeated on the c501 analyzer, resulting as 3. 31 mg/l feu accompanied by a data flag. The sample was automatically repeated, resulting as 3. 33 mg/l feu accompanied by a data flag. The sample was sent to another laboratory where it was measured using the same type of analyzers. On a second c501 analyzer at the other site, the sample resulted as 3. 58 mg/l feu. On a sysmex analyzer at the other site, the sample resulted with a value that was under the limit of detection. No adverse events were alleged to have occurred with the patient. The c501 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01459 |
| MDR Report Key | 7507855 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-11 |
| Date of Report | 2018-07-30 |
| Date of Event | 2018-04-24 |
| Date Mfgr Received | 2018-04-26 |
| Date Added to Maude | 2018-05-11 |
| 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 | 2018-05-11 |
| Model Number | NA |
| Catalog Number | 04912551190 |
| Lot Number | 290802 |
| ID Number | NA |
| 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 | 2018-05-11 |