ELECSYS MYOGLOBIN IMMUNOASSAY

MAUDE Adverse Event Report

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 2017-08-09 for ELECSYS MYOGLOBIN IMMUNOASSAY manufactured by Roche Diagnostics.

Event Text Entries

[83750420] This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[83750421] The customer stated that they received questionable results for one patient sample tested for multiple assays on the cobas 6000 e 601 module (e601). Of the questioned results, there were erroneous results for the following assays: elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), the elecsys tsh assay (tsh), the elecsys myoglobin immunoassay (myo), elecsys ferritin (ferr), the elecsys free psa immunoassay (fpsa), and the elecsys cortisol test system (cort). It was asked, but it is not known if the erroneous results were reported outside of the laboratory. Roche markets the following myo assays: elecsys myoglobin immunoassay and elecsys myoglobin stat immunoassay. It was asked, but it is not known which myo assay was used for sample testing. Roche markets the following cort assays: elecsys cortisol test system and elecsys cortisol ii. It was asked, but it is not known which cort assay was used for sample testing. The sample was collected on (b)(6) 2017 and tested on the e601 and abbott analyzers on 07/06/2017 and 07/11/2017. The customer believes that the sample may contain an interferent which interferes with the roche assays. An additional myo value of 21. 30 ug/ml was provided. It could not be clarified if this was an additional myo value from the patient sample, or if it was provided in error. A clarification has been requested. The cort results were measured after one freeze/thaw cycle of the sample. This medwatch will apply to the myo assay. Refer to the following manufacturer report reference numbers for information related to the ft3, ft4, and tsh assays: (b)(4). Refer to the medwatches with the following patient identifiers for information related to the ferr, fpsa, and cort assays: pt-(b)(6) = ferr, pt-(b)(6) = fpsa, pt-(b)(6) = cort. No adverse events were alleged to have occurred with the patient. The serial number of the e601 analyzer used at the customer site was (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1823260-2017-01651
MDR Report Key6776719
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-08-09
Date of Report2017-09-05
Date of Event2017-07-06
Date Mfgr Received2017-07-13
Date Added to Maude2017-08-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNA MICHAEL LESLIE
Manufacturer Street9115 HAGUE ROAD NA
Manufacturer CityINDIANAPOLIS IN 46250
Manufacturer CountryUS
Manufacturer Postal46250
Manufacturer Phone3175214343
Manufacturer G1ROCHE DIAGNOSTICS GMBH
Manufacturer StreetSANDHOFERSTRASSE 116 NA
Manufacturer CityMANNHEIM (BADEN-WURTTEMBERG) 68305
Manufacturer CountryGM
Manufacturer Postal Code68305
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameELECSYS MYOGLOBIN IMMUNOASSAY
Generic NameMYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
Product CodeDDR
Date Received2017-08-09
Model NumberNA
Catalog NumberASKU
Lot NumberASKU
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS
Manufacturer Address9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-09

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