MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-10 for ANTI-CCP 05031656190 manufactured by Roche Diagnostics.
[26028322]
It was noted that the customer has tested the sample at a different site on another e411 analyzer and the result was similar to the initial anti- ccp result of 38. 82 u/ml. The actual result was not provided.
Patient Sequence No: 1, Text Type: N, H10
[26131536]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[26131537]
The customer complained of erroneous results for 1 patient sample tested for anti-ccp. The erroneous results were reported outside of the laboratory. The initial anti-ccp result was 38. 82 u/ml. This result was reported outside of the laboratory. The sample was sent to 2 external laboratories where the result from a siemens immulite analyzer was 1. 79 u/ml and the result from an abbott architect analyzer was 4. 80 u/ml. The sample was also repeated on another e411 system where the result was 45. 41 with a data flag. No adverse event was reported. The e411 system serial number was (b)(4). Preventative maintenance was last performed on 11/13/2014. During performance testing, the instrument was found to be out of specification by the field service engineer. Calibration was performed on 07/16/2015 when the reagent kit was loaded onto the system. The customer uses anti-ccp once a week and runs all samples every monday. It was noted that the customer uses biorad quality controls which do not have values for anti-ccp. The customer has set a range based on the values received over time and is using that range when running quality controls. The reagent kit was recalibrated on 08/21/2015 when the calibration signals seemed lower. After recalibrating, the signal dropped lower. The quality controls at this time were within the range set by the customer. It was noted that the calibration signals obtained by the customer were too low for both levels and calibration is not performed frequently enough based on manufacturer recommendations.
Patient Sequence No: 1, Text Type: D, B5
[28088287]
Upon further investigation, various reagent and maintenance handling issues were discovered at the customer site. The customer is also using a control lot which is not specified for anti-ccp.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04116 |
| MDR Report Key | 5067028 |
| Date Received | 2015-09-10 |
| Date of Report | 2015-10-12 |
| Date of Event | 2015-08-17 |
| Date Mfgr Received | 2015-08-21 |
| Date Added to Maude | 2015-09-10 |
| 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 | ANTI-CCP |
| Generic Name | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE |
| Product Code | NHX |
| Date Received | 2015-09-10 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | 185555 |
| ID Number | NA |
| Device Expiration Date | 2015-11-29 |
| 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 | 2015-09-10 |