MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-D BLEND; SERACLONE ANTI-D BLEND

Catalog Number 802033100

Device Problems False Positive Result (1227); Defective Device (2588); Device Ingredient or Reagent Problem (2910)

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

Event Type  malfunction  

Event Description

The customer reported false positive reactions of rh(d) negative samples with seraclone anti-d blend.The customer claimed this to happen on various dates but was not able to state the exact day(s) of event.The customer reported that he observed false positive test results microscopically, when he used reagent from a nearly empty vial of anti-d blend.The customer did return seven vials of the supposedly defective product, but none of the samples that had caused false positive test results.One of the seven vials provided by the customer contained only very little reagent.Our quality control laboratory tested all vials provided by the customer in parallel to our retained seraclone anti-d blend sample.All rh(d) negative red blood cells reacted clearly negatively.We did not observe any false positive reactions.The reactions were evaluated visually, because microscopical reading of the reactions is not according to the instruction for use.Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-d blend functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

Manufacturer Narrative

This is our combined initial and final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT ANTI-D BLEND
• Type of Device: SERACLONE ANTI-D BLEND
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 6330 3; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303 ; 1033130576
• MDR Report Key: 3795145
• MDR Text Key: 16777318
• Report Number: 9610824-2014-00033
• 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,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/07/2014

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
• Device Expiration Date: 03/03/2015
• Device Catalogue Number: 802033100
• Device Lot Number: 8310140-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1