MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PTH STAT IMMUNOASSAY; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Catalog Number	04892470160
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	Hormonal Imbalance (4495)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
We received an allegation of questionable high results for 1 patient tested for elecsys pth stat immunoassay (pth stat) during a scheduled surgery to remove a parathyroid adenoma on a cobas 8000 e 602 module.The high results allegedly resulted in a longer surgery and additional tissue being removed by the surgeon.Pth had been tested at an outside laboratory by an unknown method in 2023 and the result was reportedly 137 pg/ml.The patient allegedly underwent removal of the adenoma with initial drop in her parathyroid levels from 84 pg/ml to 59 pg/ml.Since the level remained elevated additional parathyroid tissue was surgically removed along with half of her thyroid and her thymus.Subsequently, to was reported that the patient underwent testing at an outside laboratory on a siemens instrument with a parathyroid hormone level of less than 6.4 pg/ml.Reportedly, the patient then underwent an additional surgery to reimplant some of her parathyroid tissue into her abdomen to prevent deficiency of parathyroid hormone which was successful.On an unknown date, the patient reportedly went for a follow-up laboratory test at a different facility and the pth result from competitor method 1 was <6.3 pg/ml.The customer reportedly sent a sample from the patient to an external laboratory where the result from competitor method 2 was <4 pg/ml.The patient has reportedly had subsequent pth testing performed at a local facility using competitor method 1.The initial result by competitor method 1 after the tissue was reimplanted was reportedly 21 pg/ml.The "most recent" result from competitor method 1 was reportedly approximately 40 pg/ml.The patient could not remember the actual value.The patient is reportedly doing well and has "frequent" follow-up visits with a local specialist.
Additional Manufacturer Narrative
This report was initially provided to roche by fda via medwatch mw5146511.The medwatch was submitted by the patient.Roche contacted the patient for additional information.Roche also contacted the customer account where the elecsys pth stat testing was performed on the e602 module for additional information.Additional details from both parties have been included.The e602 module serial number is (b)(6).Competitor method 1 is siemens.Competitor method 2 is abbott.The customer reportedly performed interference testing where the results suggested heterophile antibodies.The customer has a laboratory procedure in place using a blocking agent to test for heterophile antibodies.The patient reportedly received a letter from the customer site indicating an interfering substance was found in the patient¿s plasma (heterophile antibody).The customer reportedly believes the e602 module is operating correctly.The customer reportedly thinks the issue is related to a patient-specific heterophile antibody interference with the roche method.Sample material from the patient was requested for an investigation, however, the customer allegedly used all of the remaining sample material when performing interference testing.The investigation is ongoing.
Additional Manufacturer Narrative
No sample material was available for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
Product labeling states: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".

• Brand Name: ELECSYS PTH STAT IMMUNOASSAY
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID 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: 18191411
• Report Number: 1823260-2023-03743
• Device Sequence Number: 7275334
• Product Code: CEW
• UDI-Device Identifier: 04015630939244
• UDI-Public: 04015630939244
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2024

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: 01/31/2024
• Device Catalogue Number: 04892470160
• Device Lot Number: 646241
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 01/31/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/23/2024; 02/02/2024
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female