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 2019-02-12 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[136004129]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[136004130]
The customer complained of questionable roche cardiac d-dimer results for 1 patient from a cobas h 232 meter serial number (b)(4) compared to the laboratory result on the c8000 analyzer. At 21:20 the d-dimer result from the laboratory was positive. The specific result was not provided. The customer stated that results greater than 0. 5 ug/ml were considered positive. At 21:27 the initial d-dimer result from the meter was 0. 10 ug/ml with a different sample tube. At 23:37 the repeat d-dimer result from the meter was 0. 10 ug/ml with the same sample tube used for the initial result. The result from the meter was reported outside of the laboratory. The result from the laboratory was given to the medical professional. There was no allegation of an adverse event. The qc was acceptable. The suspect device was requested to be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00574 |
| MDR Report Key | 8332803 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-12 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-01-17 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2019-02-12 |
| 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 | ROCHE CARDIAC D-DIMER |
| Generic Name | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS |
| Product Code | GHH |
| Date Received | 2019-02-12 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 33295310 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-12 |