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

Catalog Number 04892470190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

The reagent lot number is 646241 with an expiration date of 01/2024.The field service representative found the customer's last calibration was performed on (b)(6) 2023 and the recommended calibration was due on (b)(6) 2023.The calibration was not performed until (b)(6) 2024.He also observed minor bubbles on the reagent pack.The investigation is ongoing.

Event Description

There was an allegation of questionable pth results for 3 patient samples on a cobas e 411 module.Patient 1: the initial result was 1.31 pmol/l.On (b)(6) 2024 the sample was repeated and the results were 6.12 pmol/l and 6.08 pmol/l.Patient 2: the initial result was 1.24 pmol/l on (b)(6) 2024 the sample was repeated and the results were 66.17 pmol/l and 65.89 pmol/l.Patient 3: on (b)(6) 2024 the initial result was 1.32 pmol/l.The repeated results were 68.27 pmol/l and 65.80 pmol/l.

• Brand Name: ELECSYS PTH STAT
• Type of Device: 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 46250-0457
• MDR Report Key: 18599723
• MDR Text Key: 334881571
• Report Number: 1823260-2024-00251
• Device Sequence Number: 1
• Product Code: CEW
• Combination Product (y/n): Y
• Reporter Country Code: SF
• PMA/PMN Number: K070709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04892470190
• Device Lot Number: 706358
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1