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

Catalog Number	03333701190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable alp2 (alp ifcc gen.2) results from one patient sample tested on the cobas integra 400 plus and an unspecified cobas pro analyzer.The reporter stated they were cross-checking results from the cobas pro with the reported cobas integra.They found result repeatability issues when using the tube, but noted the results were precise when "eppendorf" tubes were used.The patient sample was run 5 times on the cobas integra.The results are: 157.07 u/l, 255.96 u/l, 151.79 u/l, 117.00 u/l, 93.91 u/l.The questionable results were not reported outside the laboratory as they did not match clinically.
Additional Manufacturer Narrative
The serial number of the customer's cobas integra 400 plus is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the calibration data; the results were within specifications.The investigation reviewed qc data provided through 09-oct-2024; the results were within specifications.Based on the available data, there is no evidence of an instrument or reagent issue.The investigation determined the event was consistent with a preanalytic issue at the customer site (blood cells or cell debris were not properly removed).Preanalytics are within the customer's responsibility.The investigation did not identify a product problem.

• 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: 20601653
• Report Number: 1823260-2024-03185
• Device Sequence Number: 8804033
• Product Code: CJE
• UDI-Device Identifier: 04015630919505
• UDI-Public: 04015630919505
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: 03333701190
• Device Lot Number: 78317901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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