MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-08-20 for ANTI-CCP 05031656190 manufactured by Roche Diagnostics.
[24989517]
The patient samples were not provided to complete the investigation.
Patient Sequence No: 1, Text Type: N, H10
[25655671]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[25655672]
The customer complained of erroneous results for 2 patient samples tested for anti-ccp. The erroneous results were reported outside of the laboratory. Patient 1 initial anti-ccp result was 128 u/ml. The repeat results from an abbott analyzer and a phadia analyzer were both "negative. " the actual results were not provided. Patient 2 (female with (b)(6)) initial anti-ccp result was 188 u/ml. The repeat results from an abbott analyzer and a phadia analyzer were both "negative. " the actual results were not provided. No adverse event was reported. The e602 analyzer serial number was (b)(4). A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2015-03994 |
| MDR Report Key | 5018159 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-08-20 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-07-16 |
| Date Mfgr Received | 2015-07-31 |
| Date Added to Maude | 2015-08-20 |
| 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 | 2015-08-20 |
| Model Number | NA |
| Catalog Number | 05031656190 |
| Lot Number | 183411 |
| 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 | 2015-08-20 |