LABSCREEN SINGLE ANTIGEN CLASS I LSA1A04

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-27 for LABSCREEN SINGLE ANTIGEN CLASS I LSA1A04 manufactured by One Lambda Inc..

Event Text Entries

[15163018] Vendor: one lambda inc relates to the ivd assay: labscreen single antigen class i -catalog ls1a04-, labscreen single antigen class ii -catalog ls2a01. These assays are luminex-r- based tests to detect and characterize the presence of hla antibodies, typically in transplant pts. Reliable determination of the antibodies is clinically important as one part of determining hla compatibility of a organ transplant recipient and donor. We have a particular pt who is highly sensitized due to multiple transplants. The labscreen results for one particular demonstrated relatively low levels of antibody to hla-dp1, with mean fluorescence intensity -mfi- value of about 2700. In our transplant program's interpretation of these results, a mfi of 2700 would indicate some level of antibody to this hla antigen, but is not a level which would rule out transplantation of a donor with this hla antigen. Subsequent flow cytometry crossmatch studies suggested that the antibody was much stronger than indicated by this assay. The laboratory, after discussion with colleagues in other medical centers, tested the pt serum after diluting the serum 1:8 with negative serum and removing igm antibodies by treating the pt serum with dithiothreitol. The repeated assay following treatment as described above resulted in a mfi value of >12,000, a value which would be a contraindication to transplant with a donor with the hla-dp1 antigen. These results suggest that this pt has high levels of hla-dp1 with an igm isotype, as the assay is intended to identify only the presence of igg isotype antibodies. What likely occurs is that the igm antibody binds to the bead for this specificity, and blocks the binding of the clinically-relevant igg antibody, thus resulting in a falsely negative or weak antibody reported for the assay. The fact that high levels of igm can act as an interfering substance in this test has the potential of causing the assay to under-report clinically relevant antibodies, which have the potential for transplant rejection.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5012364
• MDR Report Key: 1437332
• Date Received: 2009-07-27
• Date of Report: 2009-07-24
• Date Added to Maude: 2009-08-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: LABSCREEN SINGLE ANTIGEN CLASS I
• Generic Name: NONE
• Product Code: LGO
• Date Received: 2009-07-27
• Catalog Number: LSA1A04
• Lot Number: ANY
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ONE LAMBDA INC.
• Manufacturer Address: 21001 KITTRIDGE ST CANOGA PARK CA 91303280 US 91303 2801

Device Sequence Number: 2

• Brand Name: LABSCREEN SINGLE ANTIGEN CLASS II
• Generic Name: NONE
• Product Code: LGO
• Date Received: 2009-07-27
• Catalog Number: LS2A01
• Lot Number: ANY
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ONE LAMBDA, INC.
• Manufacturer Address: 21001 KITTRIDGE ST CANOGA PARK CA 91303280 US 91303 2801

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-07-27