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 2017-05-19 for ELECSYS CALCITONIN IMMUNOASSAY 06445853190 manufactured by Roche Diagnostics.
[75532551]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75532552]
The customer complained of erroneous results for 1 patient tested for elecsys calcitonin immunoassay (calcitonin) on a cobas 6000 e 601 module. The erroneous results were reported outside of the laboratory. The initial calcitonin result from the e601 module was 1296. 00 pg/ml. This result was reported outside of the laboratory. The sample was repeated on (b)(6) 2016 by the diasorin liaison method and the result was <1. 0 pg/ml. On (b)(6) 2017 a new sample was obtained and the initial calcitonin from the e601 module was 1623. 00 pg/ml. This result was reported outside of the laboratory. The sample was repeated on (b)(6) 2017 by the diasorin liaison method and the result was <1. 0 pg/ml. The results of <1. 0 pg/ml were believed to be more plausible due to the patient having a resection of thyroid glands between (b)(6) 2016 and (b)(6) 2017. The thyroidectomy had been performed prior to the results on (b)(6) 2016. There was no allegation that an adverse event occurred. The e601 module serial number was (b)(6). The patient sample was submitted for investigation. The customer? S high calcitonin results were reproduced. A general reagent issue can be excluded. The investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5
[96516805]
Further investigation of the patient sample confirmed the presence of an igm antibody which most likely caused the patient's high calcitonin results. Product labeling addresses interferences due to extremely high titers of antibodies to analyte-specific antibodies. The incidence rate of confirmed interfering factors is monitored on a quarterly basis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01047 |
| MDR Report Key | 6577898 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-19 |
| Date of Report | 2017-06-19 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2017-05-02 |
| Date Added to Maude | 2017-05-19 |
| 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 CALCITONIN IMMUNOASSAY |
| Generic Name | CALCITONIN TEST SYSTEM |
| Product Code | JKR |
| Date Received | 2017-05-19 |
| Model Number | NA |
| Catalog Number | 06445853190 |
| Lot Number | 214130 |
| 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 | 2017-05-19 |