MAUDE Adverse Event Report: ALBA BIOSCIENCE LIMITED (LTD.) ENZYME SOLUTION PAPAIN ORTHO SERA; SOLUTION, STABILIZED ENZYME, PRODUCT CODE: KSK

Model Number	FD317
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports a false negative result with orthosera papain product fd317 lot v249596 expiry 06may23.The end user reports eight donor samples generated false negative and weak positive results with the reagent.
Additional Manufacturer Narrative
Ortho¿ sera papain is used to enhance reactivity of ortho¿ sera red blood cell antigen typing reagents and red blood cells when used in in-vitro immunohematology assays.Through a customer complaint investigation, the reactivity of orthotm sera papain of the affected lots stated above has been confirmed as reduced.Based on investigation testing, the current shelf life of the lots listed above should be reduced to prevent false negative reactions when used in conjunction with ortho¿ sera red blood cell antigen typing reagents.The following lots should now be removed from use and discarded: v249596 exp.05 may 2023.V249599 exp.16 may 2023.V250681 exp.19 june 2023.The following lots should have a new reduced expiry date assigned as detailed below: v252336 exp.10 july 2023.V257490 exp.01 august 2023.A review should be undertaken on testing previously performed with the affected lots of orthotmsera papain to ensure all results recorded were as expected and no unexpected negative reactions were observed.The reduced reactivity noted as an outcome of the investigation impacts patient samples only with expected performance evident using reagent red cells (panel cells) and / or red cell suspensions prepared using proprietary diluents which include potentiators.Any results identified as anomalous should be investigated further with orthotm sera papain lots v252336 or v257490.As per the instructions for use for orthotm sera papain: do not use if turbid.Orthotm sera papain is supplied as a clear solution; any vials which show a straw coloured appearance should be discarded.Device has not evaluated by manufacturer because not availble.

• Brand Name: ENZYME SOLUTION PAPAIN ORTHO SERA
• Common Device Name: SOLUTION, STABILIZED ENZYME, PRODUCT CODE: KSK
• Manufacturer (Section D): ALBA BIOSCIENCE LIMITED (LTD.); 5 james hamilton way; milton bridge; penicuik, uk EH26 0BF; UK EH26 0BF
• Manufacturer (Section G): ALBA BIOSCIENCE LIMITED (LTD.); 5 james hamilton way; milton bridge; penicuik, uk EH26 0BF; UK EH26 0BF
• Manufacturer Contact: samuele serfilippi ; 5 james hamilton way; milton bridge; penicuik, uk EH26 -0BF ; UK EH26 0BF
• MDR Report Key: 16984021
• Report Number: 3011683976-2023-00001
• Device Sequence Number: 6654804
• Product Code: KSK
• UDI-Device Identifier: 10758750030330
• UDI-Public: 10758750030330
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: BK150246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: 05/06/2023
• Device Model Number: FD317
• Device Catalogue Number: FD317
• Device Lot Number: V249596
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown