MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+SS; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number HCG+B

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); No Apparent Adverse Event (3189)

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Patient age was provided as (b)(6) years old.

Event Description

The initial reporter questioned results not corresponding to the clinical picture for 2 patients tested for elecsys hcg+ss (hcg+ss) on a cobas 6000 e 601 module.Three samples were obtained from each patient on different dates.Patient (b)(6): on (b)(6) 2021 the result was > 0.6 miu/ml.On (b)(6) 2021 the result was 5.64 miu/ml.On (b)(6) 2021 the result was 9.04 miu/ml.Patient (b)(6): on (b)(6) 2021 the result was 10.5 miu/ml.On (b)(6) 2021 the result was 7.86 miu/ml.On (b)(6) 2021 the result was 8.89 miu/ml.All results were reported outside of the laboratory.The doctors expected results below 0.6 miu/ml based on the patient¿s history.Neither patient is pregnant.The e601 module serial number is (b)(4).

Manufacturer Narrative

Section d4, expiration date was updated.Calibration signals were within expectations.Instrument performance testing was performed after the event and was acceptable.The hcg + b results for both patients were just slightly elevated indicating no pregnancy.Oncology patients can also have elevated hcg + b result depending on the specific malignancy/tumor.No further information was provided by the customer.The investigation did not identify a product problem.Based on the information provided, the cause of the event could not be determined.

• Brand Name: ELECSYS HCG+SS
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12415346
• MDR Text Key: 272943668
• Report Number: 1823260-2021-02573
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• PMA/PMN Number: K003178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: HCG+B
• Device Catalogue Number: 03271749190
• Device Lot Number: 51653900
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1