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 2016-08-05 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[51345477]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[51345478]
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. A sample from the patient was tested for ddi on the cobas h232 analyzer in the doctor's office and the result from this sample was 1. 1 ug/ml. The 1. 1 ug/ml result was reported outside of the laboratory. The patient was then transferred to the hospital based on the result. At the hospital, a sample from the patient was tested on a c501 analyzer, resulting as < 0. 15 ug/ml. The patient was not adversely affected. The cobas h 232 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[52790646]
The customer provided the analyzer and test strips for investigation. Investigations were performed with the customer material and retention materials. Upon receipt of the customer material, it was found that temperature requirements for the sent test strips were not met. Investigation results fulfilled all requirements. The investigated material could be ruled out as a root cause. A handling issue or a sample interference issue could not be excluded out as potential root causes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01122 |
| MDR Report Key | 5851368 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-05 |
| Date of Report | 2016-08-16 |
| Date of Event | 2016-07-20 |
| Date Mfgr Received | 2016-07-21 |
| Date Added to Maude | 2016-08-05 |
| 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 |
| 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 | 2016-08-05 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 12155712 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| 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 | 2016-08-05 |