MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS; CLINICAL CHEMISTRY ANALYZER

Model Number	I400+
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they have been having issues with control recovery and proficiency survey recovery for astl aspartate aminotransferase - pyridoxal phosphate activated on the cobas integra 400 plus (serial number (b)(4)) and an unknown cobas 6000 system (serial number unknown) at a second site.The reporter repeated patient samples in order to troubleshoot the issue and found discrepant results for four patient samples.The first sample initially resulted in an ast value of 18 u/l when tested on the integra 400 plus analyzer and this value was reported outside of the laboratory.The assay was recalibrated and the sample was then repeated on the integra on (b)(6) 2021, resulting in a value of 28 u/l.The 28 u/l value was believed to be correct.The sample was also repeated three times on a cobas 6000 system at a second site on (b)(6) 2021, resulting in values of 30 u/l, 22 u/l, and 18 u/l.The field service engineer checked the integra analyzer optics and changed the halogen lamp.Control recovery improved after this.The customer then encountered issues with the second, third, and fourth complained samples.The second sample initially resulted in an ast value of 18 u/l when tested on the integra on (b)(6) 2021.The initial value was reported outside of the laboratory.The sample was repeated on the integra on (b)(6) 2021, resulting in a value of 22 u/l.The sample was also repeated on the integra on (b)(6) 2021, resulting in a value of 32 u/l.The third sample initially resulted in an ast value of 20 u/l and repeated as 17 u/l when tested on the integra on (b)(6) 2021.The initial value was reported outside of the laboratory.The sample was repeated on the integra on (b)(6) 2021, resulting with a value of 27 u/l.The repeat result was believed to be correct.The fourth sample initially resulted in an ast value of 13 u/l on the integra on (b)(6) 2021.The initial value was reported outside of the laboratory.The sample was repeated on the integra on (b)(6) 2021, resulting in a value of 20 u/l.The sample was also repeated on the integra on (b)(60 2021, resulting in a value of 24 u/l.The repeat value of 20 u/l was believed to be correct.
Additional Manufacturer Narrative
Per clarification from the customer, the correct data for the first patient sample is as follows: the first sample initially resulted in an ast value of 18 u/l when tested on the integra 400 plus analyzer and this value was reported outside of the laboratory.The sample was repeated on the integra analyzer, resulting in a value of 18 u/l.The assay was recalibrated and the sample was then repeated on the integra on (b)(6)-2021, resulting in a value of 28 u/l.The 28 u/l value was believed to be correct.The sample was also repeated once on a cobas 6000 system at a second site on (b)(6)-2021, resulting in a value of 30 u/l.A fifth patient sample also had discrepant ast results on (b)(6)-2021 prior to the change of the lamp on the integra.This sample initially resulted in an ast value of 11 u/l when tested on the integra 400 plus analyzer and this value was reported outside of the laboratory.The assay was recalibrated and the sample was then repeated on the integra on (b)(6)-2021, resulting in a value of 17 u/l.The sample was also repeated on a cobas 6000 system at a second site on (b)(6)-2021, resulting in a value of 22 u/l.The repeat value from this sample was believed to be correct.
Additional Manufacturer Narrative
The field service engineer found a loose probe.Probes were replaced and the ast assay was recalibrated.The issue was resolved after these actions.The customer ran controls and controls were within range.Quality control data appeared to be erratic, but was within range.There is no indication of a reagent or instrument performance issue.The sample centrifugation speed may have been higher than what is recommended by the tube manufacturer.Upon review of the alarm trace, multiple clot detection alarms and no fluid alarms were observed.The investigation determined the service actions resolved the issue.The following medwatch fields have been updated: d1, d2, d2b, d4, g1.

• Brand Name: COBAS INTEGRA 400 PLUS
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12355478
• Report Number: 1823260-2021-02442
• Device Sequence Number: 3451788
• Product Code: JJE
• UDI-Device Identifier: 04015630913855
• UDI-Public: 04015630913855
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: I400+
• Device Catalogue Number: 03245233001
• Device Lot Number: 41097401
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 09/22/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/15/2021; 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACUTAINE (BID); NEXPLENON; ZOLOFT (ONCE DAILY)
• Patient Age: 19 YR
• Patient Weight: 91