MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS BLOOD GROUPING REAGENTS ANTI-M (RABBIT); ANTISERA

Catalog Number 715850

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot.Based upon the results of this investigation, the reported customer issue was unable to be confirmed.All results were satisfactory.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Customer reported a false positive reaction when antigen typing a patient's sample with a possible anti-m antibody.Customer started using anti-m, lot mm593a (exp: 06.22.19), on (b)(6)2018.Positive and negative controls which are donor antigen m positive and donor antigen m negative from screening panels were run and qc was acceptable.Customer ran antigen typing for m for the patient's rbc's.The patient has an anti-m antibody and antigen reactivity came out as 2+ when customer was expecting a negative reaction.Customer is using a manual tube method.Customer confirmed that no false results were reported.Customer will send sample out to a reference lab to confirm their findings.No harm to patient.Tsc had customer repeat testing with a different lot of anti-m that customer has in stock.Tsc discussed with customer if ifu was followed.Tsc had customer also run antigen typing for anti-n.Customer will do it and agreed to call back.Patient female, (b)(6) yo.Update (b)(6) 2018: customer reported that the results from the reference lab confirmed their findings.The patient has an anti-m antibody and the antigen typing for patient red cells were negative for m antigen.Once customer received reference lab report they repeated the antigen typing for the patient and this time the result was negative as expected.Customer reported not being sure about what did happen before.But the antigen typing for this patient was antigen m negative the second time.Customer thinks this could be a human mistake not following the ifu's anti-m antiserum.

• Brand Name: BLOOD GROUPING REAGENTS ANTI-M (RABBIT)
• Type of Device: ANTISERA
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 8043552
• MDR Text Key: 128740293
• Report Number: 2250051-2018-00108
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2018

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
• Device Operator: No Information
• Device Expiration Date: 06/22/2019
• Device Catalogue Number: 715850
• Device Lot Number: MM593A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1