MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-16 for THYROXINE 12017709160 manufactured by Roche Diagnostics.
[2106154]
The user received questionable t4 results from the cobas e411 rack analyzer serial number (b)(4). Of the data provided, the result for one patient sample was discrepant. The initial result was >24. 9 ug/dl. The sample was repeated on (b)(6) 2011 and the repeat result was >24. 9 ug/dl. This result was reported outside the laboratory. The sample was repeated on (b)(6) 2011 and the result was 7. 33 ug/dl. The user called the doctor's office the morning after the >24. 9 ug/dl was originally reported and told them to disregard that value. The result of 7. 33 ug/dl was the final, corrected result reported on (b)(6) 2011. The user did not think the patient was affected but had no access to find out if any treatment was given or withheld due to the erroneous result. The user stated she had not heard of any affect to any patients. Upon evaluation of the analyzer, the field service representative determined the sample syringe was leaking and he adjusted it. He replaced the measuring cell as a precautionary measure. To verify the analyzer operation, he ran performance testing, calibration and quality control with passing results.
Patient Sequence No: 1, Text Type: D, B5
[9244702]
Other assays related to this event are reported in medwatch reports with patient identifiers: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03790 |
| MDR Report Key | 2164746 |
| Report Source | 05,06 |
| Date Received | 2011-07-16 |
| Date of Report | 2011-07-14 |
| Date of Event | 2011-06-20 |
| Date Mfgr Received | 2011-06-22 |
| Date Added to Maude | 2011-07-16 |
| 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) 68300 |
| Manufacturer Postal Code | 68300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THYROXINE |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2011-07-16 |
| Model Number | NA |
| Catalog Number | 12017709160 |
| Lot Number | 16138601 |
| ID Number | NA |
| Device Expiration Date | 2012-04-30 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9118 HAGUE ROAD NA INDIANAPOLIS NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-16 |