MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-09 for ANTIBODY TO CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) 05031656160 manufactured by Roche Diagnostics.
[3800358]
The customer first reported that since (b)(6) 2013, they had been having ongoing issues with quality control recovery on antibody to cyclic citrullinated peptide (anti-ppc). The customer started using new reagent lot 17233201 on (b)(6) 2013 on an elecsys 2010 disk analyzer. The customer ran a patient comparison on this new lot consisting of 5 patient samples. Of the five samples, one had an erroneous result that was reported outside of the laboratory. The sample initially resulted as 300. 4 u/ml. The customer was asked, but did not know when the sample was initially tested. This initial result was believed to be the correct value. The sample was repeated on (b)(6) 2013 as part of the comparison study and resulted as 189. 5 u/ml. The 189. 5 u/ml value was reported outside of the laboratory. The patient was not adversely affected. The elecsys 2010 disk analyzer serial number was (b)(4). The customer was sent a different reagent lot and repeated 20 samples that were run over the past month. The initial results for these samples were questioned but were not found to be erroneous. The medical director for the site stated that the differences were not clinically significant, so no patient reports were amended. The field service representative determined that the reagent was defective. The customer was provided a new reagent lot (173360). The field service representative cleaned the measuring cell manually, performed a high voltage adjustment, deleted previous calibrations, and performed a blank cell calibration. The customer ran calibration and quality controls. Reagent pack lot 17233201 passed calibration, but controls failed the customer's 2sd criteria. Reagent pack lot 173660 passed calibration and controls were on the mean.
Patient Sequence No: 1, Text Type: D, B5
[11124198]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11244097]
The customer did not know which reagent lot was used to initially test the sample.
Patient Sequence No: 1, Text Type: N, H10
[20900979]
A specific root cause could not be identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-06200 |
| MDR Report Key | 3395912 |
| Report Source | 05,06 |
| Date Received | 2013-10-09 |
| Date of Report | 2013-11-14 |
| Date of Event | 2013-09-12 |
| Date Mfgr Received | 2013-09-19 |
| Date Added to Maude | 2013-10-09 |
| 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 | ANTIBODY TO CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) |
| Generic Name | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) |
| Product Code | NHX |
| Date Received | 2013-10-09 |
| Model Number | NA |
| Catalog Number | 05031656160 |
| Lot Number | 17233201 |
| ID Number | NA |
| Device Expiration Date | 2013-10-31 |
| 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 | 2013-10-09 |