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 2016-06-03 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[46494561]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[46494562]
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 h 232 analyzer, resulting as 0. 71 ug/ml and this value was reported outside of the laboratory. The patient had a second sample collected approximately 1 hour later and this was tested in an external laboratory on an acl top instrument, resulting as 1187. 0 ug/l. The patient was not adversely affected. The cobas h 232 analyzer serial number is (b)(4). It was stated that the customer ran an internal control on the cobas h 232 analyzer prior to sample testing and one control level failed.
Patient Sequence No: 1, Text Type: D, B5
[46682210]
Patient Sequence No: 1, Text Type: N, H10
[48016452]
The customer provided the test strips and cobas h 232 analyzer for investigation. Temperature requirements for the test strips were not met and kept during the transport of this material. Both retention and customer materials were investigated. All investigation measurements fulfilled requirements. The investigated material can be ruled out as a failure source. It was noted that the customer used tubes which have not been evaluated for use with the test. Interferences present in the sample or an issue with processing of the test could not be ruled out as possible causes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00715 |
| MDR Report Key | 5697420 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-03 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-05-10 |
| Date Mfgr Received | 2016-05-11 |
| Date Added to Maude | 2016-06-03 |
| 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 | 2016-06-03 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 119616-10 |
| ID Number | NA |
| Device Expiration Date | 2017-01-31 |
| 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 | 2016-06-03 |