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 2018-04-20 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[106907720]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[106907721]
The customer complained of discrepant results for 1 patient tested for roche cardiac d-dimer on a cobas h232 instrument with serial number (b)(4). The d-dimer result from the h232 instrument was 0. 59 ug/ml. The d-dimer result from the laboratory using the sysmex cs-5100 method was 1. 3 ug/ml. The sample for the h232 instrument was in a lithium heparin tube and the sample for the laboratory was in a citrate tube. The samples were taken at "roughly the same time"; the lab sample was analyzed 4-6 hours later. The customer stated they had similar discrepant results for 4 other patients over the course of 1 month. The customer was not able to provide any specific results for these patients. There was no allegation that an adverse event occurred. The meter and test strips were requested for investigation. Neither the h232 instrument nor a similar device is sold in the united states. Relevant retention material roche cardiac d-dimer of lot 26452210 was measured on a cobas h232 at the investigation site with two native blood samples and two spiked blood samples (c=0. 65? G/ml and c=1. 4? G/ml); each blood sample n=three test strips. The mean of the measurements on the cobas h232 at the investigation site: first native blood sample: 0. 22? G/ml, second native blood sample: 0. 37? G/ml, first spiked blood sample (c=0. 65? G/ml): 0. 59? G/ml, second spiked blood sample (c=1. 4? G/ml): 1. 20? G/ml. The results of all the measurements meet the requirements.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01230 |
| MDR Report Key | 7446205 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-20 |
| Date of Report | 2018-05-02 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2018-04-09 |
| Date Added to Maude | 2018-04-20 |
| 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 | GHH |
| Date Received | 2018-04-20 |
| Returned To Mfg | 2018-04-20 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 27654210 |
| ID Number | NA |
| 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 | 2018-04-20 |