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 2016-08-26 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[53295084]
This event occurred in (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[53295085]
The customer stated that they received an erroneous result for one patient sample tested for roche cardiac d-dimer (ddi) on a cobas h 232 analyzer. The cobas h 232 analyzer is not sold in the united states, nor is it like or similar to a product sold in the united states. There was no report of any error messages occurring on the analyzer. The date that the event occurred was asked for, but not provided. A sample from the patient was tested for ddi on the cobas h 232 analyzer, resulting as 3. 90 ug/ml. It was asked, but it is not known if the value was reported outside of the laboratory. A different sample tube collected at the same time was tested using a different test method at a clinical commercial laboratory and this sample resulted as 63. 2 ug/ml. It was asked, but it could not be confirmed by the customer which value was considered to be correct. The patient was not adversely affected. The cobas h 232 analyzer serial number was (b)(4). It was explained to the customer that results using different methods can differ because calculation and cut-off values are different. It was also explained to the customer that since the result using the different test method indicates a high concentration of d-dimer, a hook effect may be the root cause of the discrepancy.
Patient Sequence No: 1, Text Type: D, B5
[55590814]
The customer analyzer and test strips were requested for investigation, but could not be provided. Retention materials were tested and all test results were within accordance of the testing plan. The customer agreed with the explanation that results using different methods can differ and based on the results provided, a hook effect may be the root cause of the discrepancy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01279 |
| MDR Report Key | 5906029 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-26 |
| Date of Report | 2016-09-14 |
| Date of Event | 2016-08-18 |
| Date Mfgr Received | 2016-08-18 |
| Date Added to Maude | 2016-08-26 |
| 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 | DAP |
| Date Received | 2016-08-26 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 28245810 |
| ID Number | NA |
| Device Expiration Date | 2016-11-30 |
| 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 | 2016-08-26 |