MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-31 for FOLATE II 03253678160 manufactured by Roche Diagnostics.
[15143691]
The customer stated they were receiving questionable results for folate on their modular analytics e-module (serial number (b)(4)). There were two discrepant results that were reported outside the laboratory. The laboratory repeated the tests and issued corrected reports. All repeat testing was performed on the same modular analytics e-module. The first patient had an initial folate result of 16. 43 ng/ml. The repeat result from (b)(6) 2011 was 10. 37 ng/ml. The second patient had an initial folate result from (b)(6) 2011 of 20. 00 ng/ml. The repeat result from (b)(6) 2011 was 11. 70 ng/ml. The patients were not adversely affected by the event. The field service representative could not determine the cause of this event. He replaced seals and o-rings on all syringes. He flushed the reagent and pre-cleaning probes. He ran fishing line through the sipper tubing to check for blockages. He replaced system reagents. He ran system volume and blank cell calibration with passing results. Customer performed calibration and quality control with passing results.
Patient Sequence No: 1, Text Type: D, B5
[15172984]
.
Patient Sequence No: 1, Text Type: N, H10
[15720788]
A specific root cause could not be identified. The customer was unwilling to provide any further data or information. The customer stated the issue is resolved. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02871 |
| MDR Report Key | 2108048 |
| Report Source | 05,06 |
| Date Received | 2011-05-31 |
| Date of Report | 2011-07-20 |
| Date of Event | 2011-05-12 |
| Date Mfgr Received | 2011-05-16 |
| Date Added to Maude | 2011-05-31 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOLATE II |
| Generic Name | ACID, FOLIC, RADIOIMMUNOASSAY |
| Product Code | CGN |
| Date Received | 2011-05-31 |
| Model Number | NA |
| Catalog Number | 03253678160 |
| Lot Number | 16117801 |
| ID Number | NA |
| Device Expiration Date | 2011-08-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2011-05-31 |