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 2016-09-09 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[54348243]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[54348244]
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 were no other issues with unexpected results or issues with sample errors. The patient had no known interferences. Two samples were collected from the patient at the same time. One sample was tested on the cobas h 232 analyzer, resulting with a ddi value of 0. 33 ug/ml. The second sample was tested using an unknown laboratory method, resulting with a ddi value of 2. 31 ug/ml. The results were reported outside of the laboratory to nurses, who advised the patient. The nurses then called about the event. The patient was not adversely affected. The cobas h 232 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[56572115]
A specific root cause could not be determined as the customer material was requested, but not returned. Investigations were performed on retention material from the same lot number. Relevant retention material 14008810 was measured on a cobas h232 analyzers with two native blood samples and two spiked blood samples. Each blood sample was tested three times. The results were as follows: mean of the measurements: first native blood sample: 0. 23 ug/ml. Second native blood sample: 0. 19 ug/ml. First spiked blood sample (c=0. 70 ug/ml): 0. 74 ug/ml. Second spiked blood sample (c=2. 20 ug/ml): 2. 10? U/ml. All measurements performed with this material fulfilled requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01341 |
| MDR Report Key | 5939615 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-09 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-08-26 |
| Date Mfgr Received | 2016-08-26 |
| Date Added to Maude | 2016-09-09 |
| 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 | 2016-09-09 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 14008810 |
| ID Number | NA |
| 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 | 2016-09-09 |