MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-01-26 for ELECSYS BRAHMS PCT 05056888200 manufactured by Roche Diagnostics.
[65849398]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[65849399]
The customer received questionable results for elecsys ft4 ii assay, elecsys vitamin b12 immunoassay, elecsys folate iii assay, elecsys brahms pct, and elecsys tsh assay for one patient and suspected an interference with biotin from the qizenday treatment the patient was receiving. The customer used a cobas 6000 e 601 module. The serial number was requested but was not provided. Specific data and additional information for the complaint was requested but was not provided. Information concerning if any erroneous result was reported outside the laboratory was requested but it was unknown. The patient was not adversely affected. The complaint also involved elecsys ft4 ii assay, elecsys vitamin b12 immunoassay, elecsys folate iii assay, and elecsys tsh assay. Refer to the medwatchs with patient identifiers (b)(6) for the other assays involved.
Patient Sequence No: 1, Text Type: D, B5
[68234382]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68624348]
The units of measure for the assays involved in this event were provided as follows: ft4: pmol / l. B12: pg / ml. Fol: nmol / l. Pct: ng / ml. Tsh: mu / l. Samples drawn from the patient on (b)(6) 2017, (b)(6) 2017, 01/12/2017, (b)(6) 2017, and (b)(6) 2017 were submitted for investigation. The samples were tested on a cobas e601 analyzer and a cobas e411 analyzer. Based on the results for four of the samples, an immunoglobulin that reacts with the reagent and affects the results was suspected. No interfering factor to streptavidin was found in the samples.
Patient Sequence No: 1, Text Type: N, H10
[71153733]
The biotin concentration was measured in the samples provided: (b)(6). For all of the samples drawn when the patent was known to be taking the qizenday treatment, the result was higher than the allowable concentrations specified in the method sheets of all involved assays. The result for the sample from (b)(6) 2017 when the patient may have not been taking the qizenday treatment was not above the allowable concentrations. The high biotin concentration most likely caused the issue. Interference with assays that use the biotin-streptavidin technology is possible and the therapy should be stopped for one week before measurements are done.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00158 |
| MDR Report Key | 6280280 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-26 |
| Date of Report | 2017-03-20 |
| Date of Event | 2017-01-02 |
| Date Mfgr Received | 2017-01-05 |
| Date Added to Maude | 2017-01-26 |
| 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 | 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 | ELECSYS BRAHMS PCT |
| Generic Name | DEVICE TO DETECT AND MEASURE PROCALCITONIN |
| Product Code | JLW |
| Date Received | 2017-01-26 |
| Model Number | NA |
| Catalog Number | 05056888200 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | ELECSYS BRAHMS PCT |
| Generic Name | DEVICE TO DETECT AND MEASURE PROCALCITONIN |
| Product Code | PMT |
| Date Received | 2017-01-26 |
| Model Number | NA |
| Catalog Number | 05056888200 |
| Lot Number | ASKU |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-26 |