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 2013-08-29 for COBAS E-ELECSYS ANTI-CCP 05031656190 manufactured by Roche Diagnostics.
[3953946]
The customer alleged they received questionable antibody to cyclic citrullinated peptide (accp) results of one patient on their e-module. The specific date of this event was requested but not provided. The patient's sample was initially tested undiluted, diluted 1:10, and diluted 1:100, and all three tests results were over the measuring range. The patient then had another sample tested undiluted and the result was 125. 1 u/ml. The second sample was then diluted 1:10 and the result was over the measuring range. The second sample was then diluted 1:100 and the result was 10870 u/ml. The second sample was then diluted 1:1000 and the result was 11780 u/ml. The customer then re-tested the original sample and the result was within range at about 120 u/ml, and it was reported outside the laboratory. Information on whether any of the discrepant results were reported outside the laboratory was requested but not provided. Information on whether the patient was adversely affected was requested but not provided. The accp reagent lot number and expiration date were requested but not provided
Patient Sequence No: 1, Text Type: D, B5
[10916598]
This event occurred in (b)(6) no information was provided on the specific part number involved in this event.
Patient Sequence No: 1, Text Type: N, H10
[11124660]
A definitive root cause could not be determined. It was noted that autoantibodies are heterogeneous and this gives rise to non-linear dilution phenomena for certain individual samples. It was noted that the patient's results were all above the stated cut off for the assay. It was possible discrepant results were from hook effect due to the high accp concentrations. This limitation is covered in the package labeling. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-05302 |
| MDR Report Key | 3317229 |
| Report Source | 01,05,06 |
| Date Received | 2013-08-29 |
| Date of Report | 2013-10-03 |
| Date of Event | 2013-08-19 |
| Date Mfgr Received | 2013-08-19 |
| Date Added to Maude | 2013-08-29 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 | COBAS E-ELECSYS ANTI-CCP |
| Generic Name | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) |
| Product Code | NHX |
| Date Received | 2013-08-29 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | ASKU |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-29 |