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 2016-03-17 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[40645851]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[40645852]
It was reported that the customer received erroneous results for two samples from the same patient tested for roche cardiac d-dimer (ddi) on a cobas h 232 analyzer. The erroneous results were reported outside of the laboratory. 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. The first sample resulted as 0. 34 ug/ml when tested on the cobas h 232 analyzer. The sample was also tested at another laboratory using a biomajesty 6030 analyzer using the ns auto d-dimer test method, where it resulted as 235 ug/ml. The second sample resulted as 0. 32 ug/ml when tested on the cobas h 232 analyzer on (b)(6) 2016. The sample was also tested at another laboratory using a biomajesty 6030 analyzer using the ns auto d-dimer test method, where it resulted as 55 ug/ml. A cobas h 232 d-dimer result of 0. 34 ug/ml from (b)(6) 2016 and a d-dimer result of 243 ug/ml from an outsourced laboratory were also provided, but it was not clear if these were results from a different sample or if the data represents the same results from the first or second sample. It was stated that the result from the outsourced lab was believed to be correct since it aligned with the patient's clinical condition. The patient was not adversely affected. The cobas h 232 analyzer serial number was (b)(4). A specific root cause could not be determined based on the provided information. Materials were requested from the customer for investigation, but were not provided. Measurements performed with retention materials fulfill requirements. No irregularities were seen with the retention material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-00317 |
| MDR Report Key | 5508104 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-17 |
| Date of Report | 2016-03-17 |
| Date of Event | 2016-01-26 |
| Date Mfgr Received | 2016-02-24 |
| Date Added to Maude | 2016-03-17 |
| 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 | ROCHE CARDIAC D-DIMER |
| Generic Name | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS |
| Product Code | DAP |
| Date Received | 2016-03-17 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 28231310 |
| ID Number | NA |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-03-17 |