MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-08 for APO B VER.2 TINA-QUANT APOLIPOPROTEIN B VER.2 03032639122 manufactured by Roche Diagnostics.
[59840020]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59840021]
The customer complained that the results for 1 patient sample tested for apo b ver. 2 tina-quant apolipoprotein b ver. 2 (apo b ver. 2) did not fit the patient's clinical picture. On (b)(6) 2016 the patient had an apo b ver. 2 result of 1. 44 g/l. This result was reported outside of the laboratory. On (b)(6) 2016 a new sample was obtained and the apo b ver. 2 result was 0. 00 g/l with a data flag. This result did not conform to the patient's clinical picture based on the result 2 days prior. Since other tests run at the same time were acceptable, the customer performed a 1:2 manual dilution and the result was 0. 22 g/l. These results were not reported outside of the laboratory. No adverse event occurred. The modular p800 analyzer serial number was (b)(4). An interference is suspected in the sample, however, the sample is not available for investigation.
Patient Sequence No: 1, Text Type: D, B5
[60910786]
A specific root cause could not be identified for this event. Additional information was requested for investigation but was not provided. Based on calibration and quality control data, an analyzer specific and/or reagent issue can be excluded. The previous sample that gave the result 1. 44 g/l is above the expected value. Presence of gammopathy could be a potential root cause and this is described in the product labeling. This could not be confirmed as sample was not available for investigation.
Patient Sequence No: 1, Text Type: N, H10
[61629418]
The customer indicated that the result of 0. 22 g/l from the sample obtained on (b)(6) 2016 was reported outside of the laboratory. The patient was being seen for a re-examination. Details were requested but cannot be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01741 |
| MDR Report Key | 6085116 |
| Date Received | 2016-11-08 |
| Date of Report | 2016-11-22 |
| Date of Event | 2016-10-21 |
| Date Mfgr Received | 2016-10-21 |
| Date Added to Maude | 2016-11-08 |
| 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 | APO B VER.2 TINA-QUANT APOLIPOPROTEIN B VER.2 |
| Generic Name | LOW-DENSITY LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DFC |
| Date Received | 2016-11-08 |
| Model Number | NA |
| Catalog Number | 03032639122 |
| Lot Number | 131697 |
| 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 | 2016-11-08 |