MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PTH ELECSYS E2G 300; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Model Number	PTH
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).Udi number = (b)(4).
Event or Problem Description
The initial reporter stated they received discrepant results for five patient samples tested with the elecsys pth immunoassay on a cobas 8000 e 801 module (serial number (b)(4)).No incorrect results were reported outside of the laboratory.The first patient sample initially resulted in a pth value of 12.1 pg/ml on (b)(6) 2021, which repeated as 7.95 pg/ml on (b)(6) 2021.The sample was repeated using an unknown chemiluminescence method, resulting in a value of 16 pg/ml on (b)(6) 2021.The second patient sample initially resulted in a pth value of 11.2 pg/ml on (b)(6) 2021, which repeated as 9.63 pg/ml on (b)(6) 2021.The sample was repeated using an unknown chemiluminescence method, resulting in a value of 15.40 pg/ml on (b)(6) 2021.The third patient sample initially resulted in a pth value of 4.65 pg/ml on (b)(6) 2021, which repeated as 3.88 pg/ml on (b)(6) 2021.The sample was repeated using an unknown chemiluminescence method, resulting in a value of 20.20 pg/ml on (b)(6) 2021.The fourth patient sample initially resulted in a pth value of 4.59 pg/ml on (b)(6) 2021, which repeated as 5.39 pg/ml on (b)(6) 2021.The sample was repeated using an unknown chemiluminescence method, resulting in a value of 18.20 pg/ml on (b)(6) 2021.The fifth patient sample initially resulted in a pth value of 6.81 pg/ml on (b)(6) 2021, which repeated as 6.11 pg/ml on (b)(6) 2021.The sample was repeated using an unknown chemiluminescence method, resulting in a value of 20.80 pg/ml on (b)(6) 2021.
Additional Manufacturer Narrative
For the last calibrations performed on (b)(6) 2021, the first calibrator level recovered slightly higher than expected.The second calibrator level recovered slightly lower than expected.Quality control data from 01-jun-2021 to 10-jun-2021 was ok.The investigation could not identify a product problem.The cause of the event could not be determined.No patient samples were available for investigation.A general reagent issue can most likely be excluded.

• Brand Name: PTH ELECSYS E2G 300
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12130490
• Report Number: 1823260-2021-01954
• Device Sequence Number: 3427573
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K070709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: PTH
• Device Catalogue Number: 07251068190
• Device Lot Number: 47556101
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1