MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG STAT; HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM

Model Number	E601
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hcg stat reagent lot number was 628293.The expiration date was not provided.The field service engineer (fse) found the customer poured the sample into a false bottom tube (fbt).A bubble may have occurred causing a short sample.The fse checked and adjusted the liquid level detection (lld) sensor.The customer ran calibration and qc and the instrument was operating normally.The investigation is ongoing.H3 other text : na.
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys hcg stat (hcg stat) on a cobas 6000 e 601 module.The initial result was < 1 miu/ml.This result was reported outside of the laboratory where it was questioned by the physician as the patient was pregnant.The repeat result was 16,452 miu/ml.This result was believed to be correct.
Additional Manufacturer Narrative
The device identification section was updated.Relevant fields of sections d and g were updated.Section b3 was updated.The e601 module serial number was (b)(6).Calibration was last performed on 24-jun-2023 with acceptable results.The field service engineer (fse) found the customer poured the sample into a false bottom tube (fbt) which contained bubbles causing a short sample.Product labeling states: "foam, fibrin clots, or bubbles in sample types may cause pipetting volume shortage and lead to incorrect results.When loading samples, calibrators, and controls, make sure that they do not contain any foam, fibrin clots, or bubbles.Avoid the formation of foam in all sample types (specimens, calibrators, controls)." the alarm trace showed "abnormal probe sucking" and "abnormal sample aspiration" errors.These are indicators of possible poor sample quality.The investigation determined the event was due to a preanalytical handling issue (bubbles in the sample).The issue was resolved by repeating the sample and obtaining the correct result.

• Brand Name: ELECSYS HCG STAT
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3174767531
• MDR Report Key: 17372063
• Report Number: 1823260-2023-02389
• Device Sequence Number: 20373586
• Product Code: DHA
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023
• 2 Devices were Involved in the Event: 1 2

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: 10/31/2023
• Device Model Number: E601
• Device Catalogue Number: 08890587190
• Device Lot Number: 62823901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 21 YR
• Patient Sex: Female