MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HIV COMBI PT; HIV DETECTION TEST

Model Number HIV COMBI

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) #(b)(4).This event occurred in (b)(6).On (b)(6) 2021, the field service representative retested the patient sample and the result was (b)(6).A numerical result value was not provided.The patient's sample was requested for investigation, but the sample material could not be provided.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received (b)(6) elecsys hiv combi pt results for 1 patient sample on a cobas 6000 e601 module, serial number (b)(4).On (b)(6) 2021, the patient sample was found to be (b)(6).On (b)(6) 2021, a pcr confirmatory result for the patient was (b)(6).The repeated result from the same sample was (b)(6).It is unknown if the repeated result was an hiv combi pt result or from a pcr.The (b)(6) results were reported outside of the laboratory.(b)(6).

• Brand Name: ELECSYS HIV COMBI PT
• Type of Device: HIV DETECTION TEST
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12094115
• MDR Text Key: 271727114
• Report Number: 1823260-2021-01888
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: KU
• PMA/PMN Number: BP160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2021

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
• Device Operator: Health Professional
• Device Model Number: HIV COMBI
• Device Catalogue Number: 05390095190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/30/2021
• 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
• Patient Age: 7 YR