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 2017-01-09 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[64133101]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[64133102]
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 at the doctor's office. 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 lithium heparin whole blood tube was measured on the cobas h 232 analyzer within one hour of collection and the result was 0. 48 ug/ml. The control line was visible on the test strip. A sodium citrate tube collected at the same time was tested on a stago compact instrument in a different laboratory on (b)(6) 2016 and the result was 1100 ug/l. The 1100 ug/l result was believed to be correct since the customer expected a higher value from the cobas h 232 analyzer. The patient was not adversely affected. The cobas h 232 analyzer serial number was (b)(4). Control recovery on the cobas h 232 analyzer was ok. The customer's product has been requested for investigation. Relevant retention material # 17668510 was measured on a qualified cobas h 232 analyzer with two native blood samples and two spiked blood samples (c=0. 80 ug/ml and c=2. 20 ug/ml). Each blood sample was measured on three test strips. Results: mean of the measurements on a qualified cobas h 232 analyzer: first native blood sample: 0. 27 ug/ml. Second native blood sample: 0. 33 ug/ml. First spiked blood sample (c=0. 80 ug/ml): 0. 76 ug/ml. Second spiked blood sample (c=2. 20 ug/ml): 2. 10 ug/ml. The results of all measurements fulfill requirements.
Patient Sequence No: 1, Text Type: D, B5
[67553494]
The customer's test strips and cobas h 232 analyzer were returned for investigation. The temperature requirements for the test strips were not met during shipment. Test strips from customer lot number were measured on the cobas h232 analyzer from the customer and on a qualified cobas h232 with one native blood sample and one spiked blood sample (c=1. 00 ug/ml). Each blood sample was measured twice on the cobas h232 analyzer from the customer and on the qualified cobas h232 analyzer. Mean of measurements on the cobas h232 analyzer from the customer: native blood sample: 0. 19 ug/ml. Spiked blood sample (c=1. 00 ug/ml): 0. 96 ug/ml. Mean of measurements on the qualified cobas h232 analyzer: native blood sample: 0. 19 ug/ml. Spiked blood sample (c=1. 00 ug/ml): 0. 96 ug/ml. The results of all measurements fulfill requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00036 |
| MDR Report Key | 6232287 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-09 |
| Date of Report | 2017-02-01 |
| Date of Event | 2016-12-19 |
| Date Mfgr Received | 2016-12-20 |
| Date Added to Maude | 2017-01-09 |
| 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 |
| 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 | 2017-01-09 |
| Returned To Mfg | 2017-01-12 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 17668511 |
| ID Number | NA |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-01-09 |