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 2018-06-29 for ROCHE CARDIAC D-DIMER 04877802190 manufactured by Roche Diagnostics.
[113186747]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[113186748]
The customer received a questionable low roche cardiac d-dimer result from cobas h232 meter serial (b)(4). The cobas h232 meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states. At 10. 50, the result from the cobas h232 was 0. 28. At 21. 15, the result from a sysmex cs2100 analyzer was 0. 66. No unit of measure was provided. The doctor stated he expected a difference in the results over the time frame, but not to this extent. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02151 |
| MDR Report Key | 7651821 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-29 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-06-13 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-06-29 |
| 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 | 2018-06-29 |
| Model Number | NA |
| Catalog Number | 04877802190 |
| Lot Number | 26452211 |
| 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 | 2018-06-29 |