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

Catalog Number	03333752190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer used a sample from a different patient and performed precision testing on both integra instruments with acceptable results.The customer also mixed the 1st sample and the 2nd sample from the patient in a 2:1 ratio and obtained expected results.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient tested for alp2 alkaline phosphatase acc.To ifcc gen.2 (alp2) on a cobas integra 400 plus.The initial result was 359.4 u/l.The repeat result was 214.2 u/l.These results did not match the previous alp2 result from the patient of 77 u/l from (b)(6) 2022.The customer performed precision testing with the sample and obtained results between 86.7 u/l and 178.3 u/l.The sample was repeated on a different integra 400 plus with results of 77.9 u/l, 75.7 u/l, 77.3 u/l and 74.9 u/l.A 2nd sample was obtained and the results were 124.7 u/l, 76.6 u/l, 83.4 u/l and 74.6 u/l and 76.2 u/l.No questionable results were reported outside of the laboratory.The integra 400 plus serial number was (b)(4).
Additional Manufacturer Narrative
Section b6 was updated with the unit of measure for leukocytes.Section b7 was updated.Section d10 was updated.Calibration and qc data were acceptable, therefore, a general reagent issue has been excluded.An instrument issue is not suspected as only the samples from this one patient were affected.Gammopathy and drug interferences have been exlcuded.Investigations have found that samples from patients with hyper-leukocytosis may show higher alp results due to the presence of leukocytes debris and plateletes.Based on the data provided, the investigation determined the root cause of the event is consistent with an accumulation of cells close to the sample surface due to the patient's high number of leukocytes.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The investigation conclusion was updated and the evaluation result and conclusion codes were updated.The investigation determined the event was consistent with a pre-analytical root cause related to this particular patient.

• Brand Name: ALP2 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13580140
• Report Number: 1823260-2022-00481
• Device Sequence Number: 12195232
• Product Code: CJE
• UDI-Device Identifier: 04015630919512
• UDI-Public: 04015630919512
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/22/2022

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: 07/31/2022
• Device Catalogue Number: 03333752190
• Device Lot Number: 59174901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 06/24/2022; 08/31/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 07/18/2022; 09/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETYLCYSTEIN; CEFTRIAXON; FORMOTEROL; FORMOTEROL; IPRATROPIUMBROMID; MYRTAVEN; SALBUTAMOL; SPIRONOLACTON; TORASEMID; TRANSIPEG
• Patient Sex: Unknown