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

Catalog Number	08056757190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ast results for one sample from the cobas pure c 303 analytical unit.The initial result was 6.60 u/l with a data flag.The first repeat result was 24.9 u/l with a data flag.The second repeat result was 25.8 u/l.On (b)(6) 2023, the repeat result was 50.4 u/l.It was unclear if the results were generated from the same patient sample.Clarification was requested but was not provided.
Additional Manufacturer Narrative
The reagent lot number was 736595.The expiration date was requested but was not provided.A general reagent problem could be ruled out because the quality control results are acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The customer alleged a questionable result for another patient sample from the cobas pure c 303 analytical unit.On 19-dec-2023, the initial alp (alkaline phosphatase) result was 136 u/l.The repeat result was 58.1 u/l.The questionable result was not reported outside of the laboratory.The reagent lot number was 736318.The expiration date was requested but was not provided.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent problem could be ruled out as the quality control results were acceptable.The investigation determined the issue was consistent with high leukocyte concentration of the samples leading to an accumulation of cells close to the plasma surface.In samples with hyper-leukocytosis the sample surface may show higher alp activity due to the presence of leukocytes, debris and platelets.It has been observed that sometimes alp out of primary tubes formed a gradient at the liquid surface leading to falsely high results.Falsely high alp values can occur if blood cells or cell debris are not properly removed in the pre-analytical sampling process.

• Brand Name: ALKALINE PHOSPHATASE ACC. TO 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 46250-0457
• MDR Report Key: 18363487
• Report Number: 1823260-2023-04128
• Device Sequence Number: 17623029
• Product Code: CJE
• UDI-Device Identifier: 07613336120972
• UDI-Public: 07613336120972
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 03/13/2024
• 2 Devices were Involved in the Event: 1 2

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: 08056757190
• Device Lot Number: 736595
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 03/11/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/12/2024; 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