MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-04-21 for ANTI-CCP 05031656190 manufactured by Roche Diagnostics.
[21187387]
The customer questioned the anti-ccp result of 57. 49 u/ml for this sample, tested on (b)(6) 2015, because there was a large difference between this result and the patient's result of 11300 u/ml from "last summer". It is not known if erroneous results were reported outside of the laboratory. The sample was tested undiluted and diluted. The anti-ccp result from the undiluted sample was 56. 74 u/ml. The sample was then diluted with an anti-ccp negative serum pool and tested using multiple dilution. A 2- fold dilution of the sample gave a result of 80. 37 u/ml. The sample was repeated with 5-fold dilution and the result was 131. 0 u/ml. The sample was repeated with 10-fold dilution and the result was >132. 5 u/ml. The sample was repeated with 20-fold dilution and the result was >132. 5 u/ml. The sample was repeated with 50-fold dilution and the result was 120. 8 u/ml. The sample was repeated with a 100-fold dilution and the result was 72. 53 u/ml. No adverse event was reported. The elecsys modular e170 serial number was not provided. Two samples from the patient were sent in for investigation. The results could not be reproduced. A specific root cause could not be identified during the investigation. A general reagent lot issue can be excluded. Product labeling documents autoantibodies are heterogeneous and this can cause non-linear dilution phenomena for certain individual samples. In addition, a sample dilution was not necessary as the result was within the measuring range. Recommended dilution is 1:2 to 1:5. The sample was diluted up to 1:100.
Patient Sequence No: 1, Text Type: D, B5
[21219528]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03148 |
| MDR Report Key | 4712109 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-04-21 |
| Date of Event | 2015-03-26 |
| Date Mfgr Received | 2015-03-26 |
| Date Added to Maude | 2015-04-21 |
| 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 | 0 |
| 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 | ANTI-CCP |
| Generic Name | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE |
| Product Code | NHX |
| Date Received | 2015-04-21 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | 180711 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-21 |