MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-06-22 for C-REACTIVE PROTEIN GEN.3 04956842190 manufactured by Roche Diagnostics.
[22725554]
This event occurred in (b)(6). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[22725555]
The customer initially complained of out of range quality controls (qc) for c-reactive protein gen. 3 (crpl3). The cassette with out of range qc was removed and 2 new cassettes were loaded. The customer only ran calibration and qc on the 2nd cassette and did not realize they were using a cassette without valid qc. After loading the 2 new cassettes, 125 patient samples were re-run. No additional information was provided regarding these samples. The next day qc was run again and the results were not within the acceptable range. They discarded the cassette that was not acceptable and re-ran 128 patient samples. It was discovered that 78 of these patient samples had an approximate 30% difference in recovery. The erroneous results had been reported outside of the laboratory and the results had to be corrected. The date of event for these 78 patient samples is not clear. No patient specific information has been provided. The specific results have not been provided. No adverse event occurred. The c501 analyzer serial number was (b)(4). It was noted that the 1st cassette was calibrated on a pack that was not mixed and the 2nd cassette used the same calibration. After the customer used a fresh pack and the reagent lot was calibrated appropriately, all qc and patient samples have been correct. A specific root cause could not be identified.
Patient Sequence No: 1, Text Type: D, B5
[32496535]
Based on the data provided, calibration was performed on 5 crp reagent cassettes with lot 608660 between (b)(6) 2015 and (b)(6) 2015. It was determined that the issue was caused by the reagent cassette from (b)(6) 2015. The customer changed their work process related to performing quality controls on standby reagent cassettes to avoid future confusion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03695 |
| MDR Report Key | 4860195 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-06-22 |
| Date of Report | 2015-08-18 |
| Date of Event | 2015-05-31 |
| Date Mfgr Received | 2015-06-04 |
| Date Added to Maude | 2015-06-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | C-REACTIVE PROTEIN GEN.3 |
| Generic Name | SYSTEM, TEST, C-REACTIVE PROTEIN |
| Product Code | DCN |
| Date Received | 2015-06-22 |
| Model Number | NA |
| Catalog Number | 04956842190 |
| Lot Number | 608660 |
| 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 | 2015-06-22 |