MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS TANGO INFINITY; SYSTEM, TEST, AUTOMATED BLOOD GROUPING

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/13/2017

Event Type  malfunction  

Event Description

Testing on tango infinity was performed in a batch with other samples.Pt was determined to be o positive with an anti-d which is very rare.Pt historically was also o positive with negative screens.Add'l samples were collected for possible referral to the (b)(6) reference lab for d variant possibility.An antibody screen was rerun on the new sample and was negative.A sample collected earlier in the day also revealed a negative screen.It was found later that the sample that was processed before this pt in the same batch contained anti-d and anti-c antibodies.(b)(6) was contacted regarding possible carryover and samples were sent for their investigation.We deemed the sample unusable resulting in add'l phlebotomies for the o pos pt as well as confusion and panic for a provider as well as the laboratory staff.The pt with the anti-d and anti-c has been tested numerous times in the past on the immucor echo analyzer with no adverse effects on other samples.

• Brand Name: TANGO INFINITY
• Type of Device: SYSTEM, TEST, AUTOMATED BLOOD GROUPING
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS; dreieicg 63303 DE; GM 63303 DE
• MDR Report Key: 6680422
• MDR Text Key: 79038149
• Report Number: MW5070731
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2017

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR