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

Catalog Number	03333752190
Medical Device Problem Codes	Chemical Problem (2893); Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer suspects an interfering substance in the patient sample.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable alp2 alkaline phosphatase acc.To ifcc gen.2 results for 1 patient sample on a cobas 6000 c501 module.The initial alp2 result was <3 iu/ml.The sample was repeated and the same result was obtained.A new sample was collected the next day and the result was 155 iu/ml.The result of 155 iu/ml was deemed correct as it matched the patient's previous result.
Additional Manufacturer Narrative
The qc recovery data provided was acceptable.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 18544472
• Report Number: 1823260-2024-00180
• Device Sequence Number: 8926201
• Product Code: CJE
• UDI-Device Identifier: 04015630919512
• UDI-Public: 04015630919512
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• 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): 02/27/2024

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 03333752190
• Device Lot Number: 765276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/27/2024
• 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