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

Catalog Number	03333701190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration trace data provided was acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable alp2 alkaline phosphatase acc.To ifcc gen.2 results for 2 patient samples on a cobas 6000 c501 module.This medwatch will cover alp2.Refer to medwatch with a1 patient identifier (b)(6) for information on the ldh results.On (b)(6) 2023, sample 1 had an initial alp result of 802 u/l.Th sample was repeated twice and the results were 467 u/l and 364 u/l.On (b)(6) 2023, the initial result was 355.8 u/l.The repeat result was 143.9 u/l.
Additional Manufacturer Narrative
The investigation determined the issue was consistent with a high leukocyte concentration in the samples leading to an accumulation of cells close to the plasma surface.Falsely high results can occur if blood cells or cell debris are not properly removed in the pre-analytical sampling process.The most likely root cause is a known interference caused by a pre-analytical issue.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.

• 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: 18170482
• Report Number: 1823260-2023-03681
• Device Sequence Number: 20735838
• Product Code: CJE
• UDI-Device Identifier: 04015630919505
• UDI-Public: 04015630919505
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 03/13/2024

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: 02/29/2024
• Device Catalogue Number: 03333701190
• Device Lot Number: 73043901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 03/13/2024
• 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