MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LACTATE DEHYDROGENASE ACC. TO IFCC VER.2; LACTATE DEHYDROGENASE TEST SYSTEM

Catalog Number	08057958190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration performed on (b)(6) 2021 was ok.Data was provided for one level of quality control and this was within range.A general reagent issue could be ruled out since calibration and quality control are acceptable.The customer uses non-roche reagents on the analyzer.A carry-over interference could not be excluded.Product labeling states that if you use non-roche tests, you must define all possible special washes for reagent probes to protect roche reagents from potential carryover.The sample was initially tested in the primary plasma tube.Per product labeling: "caution: plasma from primary tubes handled according to the manufacturer's instructions can still contain cells, leading to implausibly high results.One option for these cases is an application with automatic sample pre-dilution.Alternatively it is recommended to transfer the plasma from the primary tube to a secondary sample tube." the customer has stated they will start transferring primary plasma samples to a secondary tube.The investigation could not identify a product problem.The cause of the event could not be determined.This event occurred in (b)(6).Medwatch field udi number: (b)(4).
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with ldhi2 lactate dehydrogenase acc.To ifcc ver.2 on a cobas pro c 503 analytical unit (serial number (b)(4)).No incorrect results were reported outside of the laboratory.The sample initially resulted in a value of 968 u/l accompanied by a data flag.The sample was repeated with decreased sample volume, resulting with a value of 189 u/l.The sample was then repeated two more times without dilution, resulting in values of 591 u/l and 300 u/l.The sample was transferred to a sample cup and repeated on a second analyzer, resulting in a value of 189 u/l.The sample cup was also repeated five more times on the complained analyzer, resulting in values of 187 u/l, 190 u/l, 189 u/l, 186 u/l, and 189 u/l.

• Brand Name: LACTATE DEHYDROGENASE ACC. TO IFCC VER.2
• Common Device Name: LACTATE DEHYDROGENASE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12131844
• Report Number: 1823260-2021-01959
• Device Sequence Number: 3427575
• Product Code: CFJ
• UDI-Device Identifier: 07613336121368
• UDI-Public: 07613336121368
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K964457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: 12/31/2021
• Device Catalogue Number: 08057958190
• Device Lot Number: 524673
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1