MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-01 for T4 12017709122 manufactured by Roche Diagnostics.
[4266161]
The customer reported that they received questionable results for 5 samples from the same patient tested for thyroxine (t4) and t uptake. The customer declined to provide any additional information for t uptake. Of the 5 samples, 3 were found to have erroneous results. All initial results from these samples were questioned by the physician since the patient's thyroid had been removed. All 3 of these samples were repeated at another laboratory and these repeat results were believed to be correct. It was asked, but it is not known what specific methodology was used at the other laboratory. The customer stated that the other laboratory used an immunoassay method. The first sample initially resulted as 17. 6 ug/ml and this value was reported outside of the laboratory. The sample was repeated four additional times on (b)(6) 2013 in order to verify the initial reported result and the repeat results were 17. 8 ug/ml, 18. 25 ug/ml, 18. 02 ug/ml, and 18. 32 ug/ml. The sample was sent to another laboratory and tested on (b)(6) 2013, where it resulted as 8. 5 ug/ml. The repeat result of 8. 5 ug/ml from the other laboratory was believed to be correct. A second sample from the same patient was initially tested on (b)(6) 2013 resulting as 17. 6 ug/ml and this value was reported outside of the laboratory. The sample was sent to another laboratory and tested, where it resulted as 7. 9 ug/ml. The repeat result of 7. 9 ug/ml from the other laboratory was believed to be correct. A third sample from the same patient was initially tested on (b)(6) 2014 and resulted as 21. 1 ug/ml and this value was reported outside of the laboratory. The sample was sent to another laboratory and tested, where it resulted as 9. 8 ug/ml. The repeat result of 9. 8 ug/ml from the other laboratory was believed to be correct. The patient was not adversely affected. The samples were initially tested on e602 analyzer, serial number (b)(4). The patient's physician did indicate that many of his patients take biotin for nails and hair, but this patient did not indicate that she was taking it. The physician admitted that the patient may not comment on biotin supplementation. Labeling for the assay states that samples should not be taken from patients receiving therapy with high biotin doses until at least 8 hours following the last biotin administration. The customer declined a service visit as the customer believes the issue to be isolated to one patient.
Patient Sequence No: 1, Text Type: D, B5
[11596771]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11850447]
The customer has clarified that they have not been able to determine if the samples sent to the reference laboratory were from the same sample drawings or tubes that were run on the e602 analyzer.
Patient Sequence No: 1, Text Type: N, H10
[18566173]
A specific root cause could not be determined. From the information provided, a reagent issue most likely can be excluded.
Patient Sequence No: 1, Text Type: N, H10
[19396372]
It has been confirmed that the correct units of measurement for the t4 assay are ug/dl.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-02247 |
| MDR Report Key | 3717218 |
| Report Source | 05,06 |
| Date Received | 2014-04-01 |
| Date of Report | 2014-04-24 |
| Date of Event | 2013-11-19 |
| Date Mfgr Received | 2014-03-10 |
| Date Added to Maude | 2014-04-01 |
| 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 | 0 |
| 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 | T4 |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2014-04-01 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 17416502 |
| ID Number | NA |
| Device Expiration Date | 2015-01-31 |
| 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 | 2014-04-01 |