MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LACT GEN.2; LACTIC ACID TEST SYSTEM

Catalog Number	03183700190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).Medwatch field facility name - the full facility name was provided as (b)(4).
Event or Problem Description
The customer stated that they received an erroneous result for one patient sample tested for lact2 lactate gen.2 (lact) on a cobas integra 400 plus (i400+).The sample initially resulted as 0.11 mmol/l and this value was reported outside of the laboratory to the ward.The result did not match previous results of the patient, so the ward complained about the result.Controls were measured on the lact assay and they were found to be too low.The customer changed the reagent cassette and repeated the sample.The repeat result of the sample was 1.78 mmol/l.Controls were repeated on the new cassette and the values were within range, matching previous values.No adverse events were alleged to have occurred with the patient.The i400+ analyzer serial number was (b)(4).The investigation was unable to find a definitive root cause.

• Brand Name: LACT GEN.2
• Common Device Name: LACTIC ACID TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7713486
• Report Number: 1823260-2018-02452
• Device Sequence Number: 11029209
• Product Code: KHP
• UDI-Device Identifier: 04015630918911
• UDI-Public: 04015630918911
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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: 02/28/2019
• Device Catalogue Number: 03183700190
• Device Lot Number: 30875201
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1