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

Model Number E601

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

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

Event Date 01/04/2023

Event Type  malfunction  

Event Description

We received an allegation of low questionable results for 3 patients' plasma samples tested with elecsys hcg+b (hcg+b) assay on a 6000 e601 immunoassay analyzer compared to a different e601 module.Sample 1: on (b)(6) 2023: initial result: 3 miu/ml on (b)(6) 2023: repeat result: 434 miu/ml sample 2: on (b)(6) 2023: initial result: 69 miu/ml.Repeat result: < test.Sample 3: on an unspecified date in 2023: initial result: < test.Repeat result: > test.The questionable results were reported outside the laboratory.The physician questioned the results as they did not match the patient's clinical picture and the ultrasound.The repeat results were deemed to be correct as they matched the patients' clinical picture.The hcg+b reagent lot number was 643770.The expiration date was not provided.

Manufacturer Narrative

Sometime in (b)(6) 2023 the field service engineer (fse) did the preventive maintenance.And on (b)(6) 2023 the fse checked the instrument and changed both measuring cells and ran blank cell on measuring cell 2.The fse did a photo multiplier high voltage adjustment on cell 2.The hcg+b test was run on cell 1.The fse also did a performance check and the instrument was performing according to specifications.The customer performed calibration and qc and they were acceptable.

Manufacturer Narrative

Sections d, d1, d2, d2b, d4 and g4 were updated.The most recent calibrations and qc were acceptable.The provided information for the pre-analytics indicated that the provided spin time was outside of the manufacturer's (greiner) recommendations (1800¿2200 g for 10-15 minutes).The investigation determined that the event was most likely due to a preanalytic issue at the customer site.

• Brand Name: ELECSYS HCG+B
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16921462
• MDR Text Key: 315425748
• Report Number: 1823260-2023-01623
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: E601
• Device Catalogue Number: 03271749160
• Device Lot Number: 64377005
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1