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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

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ROCHE DIAGNOSTICS ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE Back to Search Results
Model Number TSH
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/06/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). The customer performed a tsh dilution test with the following results: original: 15. 100 uiu/ml, diluted: 14. 200 uiu/ml, diluted: 14. 200 uiu/ml, x10 diluted:14. 200 uiu/ml.
 
Event Description
The customer questioned thyroid results for 1 patient sample tested for elecsys tsh (tsh), elecsys ft4 iii (ft4 iii), and elecsys ft3 iii (ft3 iii) on a cobas e 801 module compared to the accuraseed method. The patient sample was submitted for investigation where discrepant results were identified for tsh and ft4 iii between the customer's e801 module, the architect method and an e801 module used at the investigation site. The initial results from the customer site were reported outside of the laboratory. This medwatch will cover tsh. Refer to medwatch with patient identifier (b)(4) for information on the ft4 iii results. Refer to the attached data for the patient results. The customer's e801 module serial number was (b)(4) the e801 module serial number used at the investigation site was (b)(4). The tsh reagent lot number used at the investigation site was 416233 with an expiration date of oct-2020.
 
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Brand NameELECSYS TSH ASSAY
Type of DeviceRADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM 68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key9775363
MDR Text Key220323956
Report Number1823260-2020-00605
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K961491
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSH
Device Catalogue Number07028091190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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