MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA; AUTOMATED PREANALYTICAL SYSTEM

Model Number MPA

Device Problem False Positive Result (1227)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Qc at the time of the event was within range.Error data and photos from the mpa were reviewed.Preventive maintenance had been performed on the mpa.It was confirmed that the customer discards all hitachi cups from the aliquot rack prior to replacing the rack onto the mpa aliquoter.The customer has had no further issues.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received discrepant sodium (na), potassium (k), albumin, calcium, creatinine, crp, total protein, uric acid results for two patient samples with a cobas 8000 cobas ise module.The samples were processed on a modular pre-analytics (mpa) system and then tested on the cobas 8000 cobas ise module with the following results.Sample id (b)(6): on (b)(6) 2021: the initial na result was 108 mmol/l.The repeated na result was 109 mmol/l.The initial k result was 3.4 mmol/l.The initial albumin result was 26 g/l.The initial creatinine result was 84 umol/l.The initial total protein result was 51 g/l.The initial uric acid result was 0.28 mmol/l.The initial crp result was 3 mg/l.On (b)(6) 2021: the second repeated na result was 139 mmol/l.The repeated k result was 4.4 mmol/l.The repeated albumin result was 34 g/l.The repeated creatinine result was 110 umol/l.The repeated total protein result was 66 g/l.The repeated uric acid result was 0.37 mmol/l.The repeated crp result was 4 mg/l.Sample id (b)(6).On (b)(6) 2021: the initial na result was 107 mmol/l.The repeated na result was 108 mmol/l.The initial k result was 3.3 mmol/l.The initial calcium result was 1.9 mmol/l.The initial albumin result was 30 g/l.The initial creatinine result was 58 umol/l.The initial total protein result was 50 g/l.On (b)(6) 2021: the second repeated na result was 142 mmol/l.The repeated k result was 4.3 mmol/l.The repeated calcium was 2.5 mmol/l.The repeated albumin result was 41 g/l.The repeated creatinine result was 81 umol/l.The repeated total protein result was 68 g/l.The initial results were from hitachi cups from aliquots made by the mpa.The repeat results were from the primary tube.The questionable results were reported outside of the laboratory.The reagent lot numbers and expiration dates were requested but not provided.

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12745321
• MDR Text Key: 279934187
• Report Number: 1823260-2021-03203
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• 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: 11/03/2021

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: MPA
• Device Catalogue Number: 04993543001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 11/03/2021
• 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: 71 YR