MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH TANGO INFINITY; AUTOMATED BLOOD BANK ANALYSER SYSTEM

Model Number 850000010

Device Problems False Positive Result (1227); Improper or Incorrect Procedure or Method (2017); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported that lumps of red blood cells were causing the appearance of positive results in the anti-d reagent of erytype s rhd confirm as well as with erytype s abd+rev.A1, b when used on tango infinity.The issue was reported as a follow-up of a previous complaint investigation.In three samples the result for rh d was false positive.The issue did return on (b)(6) 2018 when the customer ran three patients and the first two were o-pos results were anti-a 2+ anti-b neg anti-d1 pos anti-d2 pos negative control 1+ and reverse a1&b both 4+.A field service engineer went on site on 10/24/2018 leaving the instrument performing in specification.The customer confirmed no further instances of false positive results.On (b)(6) 2018 the customer had additional instances of rh negative donor coming up with +2 positive results.An engineer was dispatched to the site.He found that the cause for the issue was contaminated/compromised bromelin.The bromelin in the reagent bottle appeared cloudy.The issue was resolved upon making a new bottle of bromelin in a clean glass bottle.This same issue happened previously, and the same resolution was found by the fse at that time.The instrument related complaint will be closed as unconfirmed, because of an unintended use by customer using not thoroughly cleaned glass bottles for the diluted bromelin, which resulted in early contamination when this reagent was on board.The affected instrument was reported to operate within specification.

Event Description

The customer reported that lumps of red blood cells were causing the appearance of positive results in the anti-d reagent of erytype s rhd confirm as well as with erytype s abd+rev.A1, b when used on tango infinity.The issue was reported as a follow-up of a previous complaint investigation.In three samples the result for rh d was false positive.The issue did return on (b)(6), 2018 when the customer ran three patients and the first two were o-pos results were anti-a 2+ anti-b neg anti-d1 pos anti-d2 pos negative control 1+ and reverse a1&b both 4+.A field service engineer went on site on 10/24/2018 leaving the instrument performing in specification.The customer confirmed no further instances of false positive results.On (b)(6) 2018 the customer had additional instances of rh negative donor coming up with +2 positive results.Our quality control laboratory tested their retention sample of bromelin for erytype and confirmed that the allegedly defective lot of bromelin for erytype functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.An engineer was dispatched to the site.He found that the cause for the issue was contaminated/compromised bromelin.The bromelin in the reagent bottle appeared cloudy.The issue was resolved upon making a new bottle of bromelin in a clean glass bottle.This same issue happened previously, and the same resolution was found by the fse at that time.The instrument related complaint will be closed as unconfirmed, because of an unintended use by customer using not thoroughly cleaned glass bottles for the diluted bromelin, which resulted in early contamination when this reagent was on board.The affected instrument was reported to operate within specification.

Manufacturer Narrative

This is our final report on this incident.

• Brand Name: TANGO INFINITY
• Type of Device: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 8073402
• MDR Text Key: 129333697
• Report Number: 9610824-2018-00079
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: (01)07611969961719
• Combination Product (y/n): N
• PMA/PMN Number: BK150327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 850000010
• Device Catalogue Number: 850000010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BROMELIN FOR ERYTYPE, LOT 8824240-00.; ERYTYPE S ABD+REV A,B, LOT 8807040.; ERYTYPE S ABD+REV A,B, LOT 8807040.; ERYTYPE S RH CONFIRM, LOT 8806040.; ERYTYPE S RH CONFIRM, LOT 8806040.