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

Catalog Number	08056757190
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	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of discrepant results for 2 patient samples tested for alkaline phosphatase acc.To ifcc gen.2 (alp2) on a cobas c 503 analytical unit.Patient 1 initial result was 217 u/l.The sample was repeated twice with results of 165 u/l and 97.4 u/l.On (b)(6) 2024 patient 2 initial result was 507 u/l.The sample was repeated twice with results of 268 u/l and 134 u/l.
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).For patient 1: no issues were observed on the reaction monitor data.Repeatability testing was performed and the results were within specification.The investigation is ongoing.
Additional Manufacturer Narrative
Discrepant alp2 results were provided for an additional 8 patient samples tested on 2 of the customer's c503 analyzers.The following samples were run on serial number (b)(6).On 01-jun-2024 sample number (b)(6) initial result was 206 u/l.The sample was repeated twice with results of 146 u/l and 133 u/l.On 19-jun-2024 sample number (b)(6) initial result was 231 u/l.The sample was repeated twice with results of 134 u/l and 113 u/l.On 20-jun-2024 sample number (b)(6) initial result was 219 u/l.The sample was repeated twice with results of 129 u/l and 116 u/l.On 03-jul-2024 sample number (b)(6) initial result was 774 u/l.The sample was repeated twice with results of 189 u/l and 86 u/l.On 13-jul-2024 sample number (b)(6) initial result was 231 u/l.The sample was repeated twice with results of 141 u/l and 137 u/l.On 15-jul-2024 sample number (b)(6) initial result was 244 u/l.The sample was repeated twice with results of 190 u/l and 143 u/l.The following samples were run on serial number 22k0-07.On 04-jun-2024 sample number (b)(6) initial result was 313 u/l.The sample was repeated twice with results of 102 u/l and 104 u/l.On 28-jun-2024 sample number (b)(6) initial result was 642 u/l.The sample was repeated twice with results of 402 u/l and 226 u/l.
Additional Manufacturer Narrative
For c503 analyzer serial number (b)(6): the hardware performance check results suggest issues with cell rinse functionality.The customer submitted 6 patient samples for investigation.The investigation tested the samples to determine if there was any effect using the pre-dilution application.There was no change in the recovery of patient samples between the standard alp application and the pre-dilution application.The high alkaline phosphatase (alp) results were likely due to a high leukocyte concentration 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.The investigation did not identify a product problem.

• 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
• MDR Report Key: 19037322
• Report Number: 1823260-2024-01028
• Device Sequence Number: 18184503
• Product Code: CJE
• UDI-Device Identifier: 07613336120972
• UDI-Public: 07613336120972
• 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,Followup
• Report Date (Section B): 10/04/2024

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: 08056757190
• Device Lot Number: 765757
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 09/24/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 08/06/2024; 10/04/2024
• 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 Sex: Unknown