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 2017-11-16 for D-DIMER 04912551190 manufactured by Roche Diagnostics.
[93352737]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[93352738]
The customer alleged that they had received a questionable tina-quant d-dimer gen. 2 (d-dimer) result on the cobas 8000 c 502. On (b)(6) 2017 the customer received the initial d-dimer result of 4724 ug/l on the siemens bcs xp analyzer. On (b)(6) 2017 the same sample was tested on the c 502 module with a d-dimer result of 193 ug/l and a repeat result of 213 ug/l. The sample was retested with a d-dimer result of 183 ug/l on the c 502 module. The same sample was tested with a 1:3 automatic dilution and the d-dimer result was 198 ug/l on the c 502 module. It was asked but not known which result is deemed to be correct. It was asked but not known if an erroneous result was reported outside of the laboratory. There was no allegation of an adverse event. The d-dimer reagent lot number was 24988201. The expiration date was requested but not provided. On (b)(6) 2017 a new sample was tested on the siemens bcs xp and the d-dimer result was 5159 ug/l. On (b)(6) 2017 the new sample was tested on the c 502 module and the d-dimer result was 161 ug/l with a repeat result of 209 ug/dl. The d-dimer reagent lot number used on (b)(6) 2017 was 262972. The expiration date was requested but not provided. The patient was sent to a specialty heart hospital for syncope. There was no heart insufficiency diagnosed. The investigation reviewed the customer's calibration and quality control data. The calibration was inconspicuous and the quality control was acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02636 |
| MDR Report Key | 7037803 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-16 |
| Date of Report | 2017-12-08 |
| Date of Event | 2017-10-23 |
| Date Mfgr Received | 2017-10-24 |
| Date Added to Maude | 2017-11-16 |
| 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 | D-DIMER |
| Generic Name | FIBRIN SPLIT PRODUCTS |
| Product Code | GHH |
| Date Received | 2017-11-16 |
| Model Number | NA |
| Catalog Number | 04912551190 |
| Lot Number | 24988201 |
| 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 | 2017-11-16 |