MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	08429324160
Medical Device Problem Codes	High Test Results (2457); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	Diarrhea (1811)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cobas 6000 e 601 serial number was (b)(6).The field service engineer checked the analyzer and was unable to determine a cause.He found crystallization at the tip of the sample probe which he cleaned.He adjusted the prewash sipper nozzle, checked the prewash sipper, and ran performance testing.He ran a high voltage adjustment and repeated performance testing and blank cell calibration which passed.
Event or Problem Description
There was an allegation of analyzer alarms and a questionable tsh elecsys result from the cobas 6000 e 601 analyzer.The initial result for the patient was 6.78 uiu/ml.The patient reportedly had a tsh result from a different sample from just a few days earlier that was normal.No specific data was provided.The nurse allegedly asked the laboratory to send the patient sample for confirmation testing.The result from a reference laboratory using an unknown methodology was reported to be 2.54 uiu/ml.The patient allegedly had already been taking a synthroid dose of 75 mcg/day.Reportedly, when the physician received the initial tsh result of 6.78 uiu/ml, the dosage was changed to 100 mcg/day and the patient was discharged.The customer alleged the patient reported diarrhea but it was unknown if this was related to the increase in medication dosage.The customer allegedly was not aware of any adverse consequence of the increase in dosage for the patient.Reportedly, the customer communicated the corrected result to the patient's physician and reportedly the patient's medication dosage was brought back down to the prior dosage.There was no allegation of an adverse impact to the fetus.
Additional Manufacturer Narrative
Medwatch field "b7 other relevant history" updated.After service, the customer performed calibration and qc for all assays with successful results.The patient sample is not available for investigation.The investigation reviewed the calibration performed on (b)(6) 2024 and the results were within specifications.The investigation reviewed the qc data and the results were within specifications.The investigation reviewed the customer's handling of patient samples.The reported patient sample was centrifuged for 5 minutes at 2500 rcf.The centrifugation time may be shorter than recommended and the speed may be faster than the recommended guidelines.The investigation reviewed the alarm trace and abnormal sample aspiration errors were noted.These are indicators of possible poor sample quality.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TSH ELECSYS COBAS E 200 V2
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20189935
• Report Number: 1823260-2024-02620
• Device Sequence Number: 18178508
• Product Code: JLW
• UDI-Device Identifier: 07613336157626
• UDI-Public: 07613336157626
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K961491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 08429324160
• Device Lot Number: 76826101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Female