MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-21 for T4 12017709122 manufactured by Roche Diagnostics.
[3099094]
The customer received questionable thyroxine (t4) results and provided data for eight patient samples from cobas e601, serial number (b)(4). Of the data provided, the results for three patient samples were discrepant. The customer had loaded a standby pack of reagent and performed calibration. The controls following the calibration failed. They repeated the controls but only for the current pack of reagent in use and not the standby pack. They continued to run and report patient results without repeating controls on the standby pack of reagent. Repeat testing was performed on (b)(6) 2012 on cobas e601, serial number (b)(4). All results are in ug/dl. Patient sample (b)(6) initial result was 11. 86, repeat result was 7. 50. Patient sample (b)(6) initial result was 11. 90, repeat result was 7. 21. Patient sample (b)(6) initial result was 11. 61, repeat result was 7. 06. The repeat results were believed to be correct. The patients were not adversely affected. The field service representative determined there was contamination. The customer replaced the contaminated standby reagent pack and recalibrated using another pack of t4 reagent. Calibration and qc were acceptable to the customer. The field service representative ran performance testing with all results in specification.
Patient Sequence No: 1, Text Type: D, B5
[10387913]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[10451062]
The investigation determined the most likely reason for the false high results was a calibration issue or a calibrator handling issue. It was noted the signal of calibrator 1 was significantly elevated and the controls were found out of range on (b)(4) 2012 and (b)(4) 2012. Further clarification was not possible because the customer could not verify that the correct calibrators were used or the condition of the calibrators.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-06482 |
| MDR Report Key | 2883067 |
| Report Source | 05,06 |
| Date Received | 2012-12-21 |
| Date of Report | 2013-01-08 |
| Date of Event | 2012-12-04 |
| Date Mfgr Received | 2012-12-06 |
| Date Added to Maude | 2012-12-21 |
| 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 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 | T4 |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2012-12-21 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 16808401 |
| ID Number | NA |
| Device Expiration Date | 2013-08-31 |
| 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 | 2012-12-21 |