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

Catalog Number	03333752190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas integra 400 plus analyzer serial number was (b)(6).Qc was in range on the morning of the event.The field service engineer (fse) found that probe c was installed incorrectly.He replaced probe c.The fse did a performance check and fond that the instrument was performing within specifications.Investigation is ongoing.
Event or Problem Description
Hold pn 9/11.We received an allegation about discrepant results for 2 patients' plasma samples tested with alkaline phosphatase gen.2 (alp2) assay on a cobas integra 400 plus analyzer.Sample 1 (patient 1): initial result: 15 u/l.1st repeat result: 67 u/l.2nd repeat result: 425 u/l.Sample 2 (patient 2): initial result: 15 u/l.1st repeat result: 392 u/l.The physician questioned the results.The samples were then repeated.The results of 425 u/l for sample 1 and 392 u/l for sample 2 were deemed to be correct based on the patients' previous results.
Additional Manufacturer Narrative
Upon review of the alarm trace, alarms indicating no fluid detection and hardware controller alarms were observed.As controls were within range, there was no indication of a reagent performance issue.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17719128
• Report Number: 1823260-2023-02939
• Device Sequence Number: 15257160
• Product Code: CJE
• UDI-Device Identifier: 04015630919512
• UDI-Public: 04015630919512
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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 Catalogue Number: 03333752190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/13/2023
• 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 Age: 60 YR
• Patient Sex: Male