MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALP2 ALP IFCC GEN.2; NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Catalog Number	03333701190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable alp2 alkaline phosphatase acc.To ifcc gen.2 results from over fifteen patient samples tested on the cobas 8000 cobas c 502 module with serial number (b)(4).The initial results were reported outside of the laboratory.The qc went out of range after the patient samples were run which prompted the reporter to rerun the samples.The reporter stated that they believe there was a reagent probe alarm with the reagent pack that was in use.The reporter did not realize the results were reported.The reporter was able to provide the following examples of discrepant results: sample 1 - the initial result was 62 u/l.The repeat result was 118 u/l.Sample 2 - the initial result was 196 u/l.The repeat result was 374 u/l.Sample 3 - the initial result was 63 u/l.The repeat result was 118 u/l.Sample 4 - the initial result was 170 u/l.The repeat result was 332 u/l.Sample 5 - the initial result was 92 u/l.The repeat result was 168 u/l.Sample 6 - the initial result was 72 u/l.The repeat result was 140 u/l.The repeat results were deemed correct.
Additional Manufacturer Narrative
The customer removed the current reagent pack and replaced it with a standby reagent pack of the same lot number.The qc was run and was reported to be in range.This reagent pack was used when the patient samples were rerun.The field service engineer (fse) inspected the module and was not able to determine the cause of the issue.The fse was not able to reproduce the failure.He then verified the proper internal and external rinses of the sample and the reagent probes.He also verified the proper operation of the rinse mechanism.He verified the module's performance by a precision study using control material.The results were acceptable.The 18-sep-2022 calibration from the digital laboratory management software was within specifications.The provided qc from the digital laboratory management software did not indicate the results and the customer's target means and ranges.The qc appeared to be acceptable prior to the event, went out of range low, and was back in range based on the appearance of the chart.The provided alarm trace from the digital laboratory management software contained "abnormal aspiration" and "abnormal sample aspiration" errors.These are indicators of possible poor sample quality.There were no further issues reported by the customer after the reagent pack was replaced.The investigation determined the service actions resolved the issue.

• Brand Name: ALP2 ALP IFCC GEN.2
• Common Device Name: NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES
• 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: 15852708
• Report Number: 1823260-2022-03751
• Device Sequence Number: 14709273
• Product Code: CJE
• UDI-Device Identifier: 04015630919505
• UDI-Public: 04015630919505
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

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: 03/31/2023
• Device Catalogue Number: 03333701190
• Device Lot Number: 64607701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown