MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P612 PRE-ANALYTICAL SYSTEM

Model Number P612

Device Problems False Negative Result (1225); Failure to Read Input Signal (1581)

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

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : na.

Event Description

The initial reporter stated they received questionable results for two patient samples tested with elecsys hiv duo on cobas e 801 module (serial number unknown).No questionable results were reported outside of the laboratory.A serum tube of the first sample was processed on a cobas p612 pre-analytics system and tested on the e 801 analyzer, resulting in an hiv duo value of 162 coi (reactive).The edta plasma tube was then repeated on the e 801 analyzer, resulting in an hiv duo value of 0.235 coi (non-reactive).The sample was repeated on an advia analyzer, resulting in a value of 0.17.The units of measure and interpretation of the advia value are unknown.A serum tube of the second sample was processed on a cobas p612 pre-analytics system and tested on the e 801 analyzer, resulting in an hiv duo value of 570 coi (reactive).The edta plasma tube was then repeated on the e 801 analyzer, resulting in an hiv duo value of 0.05 coi (non-reactive).The serum tube of the sample was repeated on an advia analyzer, resulting in a value of > 12.The edta plasma tube of the sample was repeated on an advia analyzer, resulting in a value of < 0.05.The units of measure and interpretation of the advia values are unknown.

Manufacturer Narrative

Medwatch field d4.Has been updated.The serial number of the cobas e 801 module is (b)(4).

Manufacturer Narrative

The samples were initially tested on (b)(6) 2023.Repeat testing occurred on (b)(6) 2023.Non-reactive results were expected for both patient samples.For patient sample 2, the edta tube had an additional hivduo repeat value of 0.259 coi (non-reactive).Medwatch field b3 has been updated.

Manufacturer Narrative

The investigation determined that only samples processed on the cobas p612 pre-analytics system showed reactive results in the hiv assays and the edta samples show a non-reactive result as expected.A performance issue with the elecsys hiv duo reagent can be ruled out.Further investigations will occur with the cobas p612 pre-analytics system.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS P612 PRE-ANALYTICAL SYSTEM
• Type of Device: PRE-ANALYTICAL SYSTEM
• 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: 17061177
• MDR Text Key: 317657880
• Report Number: 1823260-2023-01837
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: P612
• Device Catalogue Number: 08484783001
• Device Lot Number: 622749
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• 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