FDA Adverse Event Malfunction Summary report: N

SEARCH-CYTE TCS 0.8%

MDR report key: 8145818 · Received December 10, 2018

Report

Report Number: 3002806769-2018-00001
Event Type: Malfunction
Date Received: December 10, 2018
Date of Event: September 1, 2015
Report Date: September 11, 2015
Manufacturer: MEDION GRIFOLS DIAGNOSTICS AG
Product Code: KSZ
PMA / PMN Number: BK130067
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

IN CONCLUSION: IT DOES NOT SUGGEST THAT THE DEVICE MAY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THERE IS NO EVIDENCE THAT THE PRODUCT DID MALFUNCTION AND THE TEST RESULT IS DUE TO THE PATIENT CHARACTERISTICS. IT IS ALSO IMPORTANT TO EMPHASIZE THAT THE SCREENING HAS REACTED POSITIVE AND THAT IN ANY CASE A FURTHER INVESTIGATION TO DETERMINE THE TYPE OF ANTIBODY IS NECESSARY.

Description of Event or Problem · 1

ONE CUSTOMER HAS TESTED A PATIENT'S SAMPLE KNOWN TO HAVE ANTIBODIES ( ANTI-K AND ANTI-S) WITH A COMPETITOR'S IDENTIFICATION PANEL AND IDENTIFIED THE TWO ANTIBODIES. THE PATIENT HAS BEEN TRANSFUSED CORRECTLY WITH COMPATIBLE UNIT (K NEGATIVE AND S NEGATIVE BLOOD UNIT). AFTER TRANSFUSION THE SCREENING TESTING WAS PERFORMED USING MEDION GRIFOLS DIAGNOSTICS AG SEARCH-CYTE TCS 0.8% PANEL, REF. 213655, LOT 644715010, EXP. 2015-SEP-12. THE SCREENING GAVE A POSITIVE RESULT HOWEVER; THE SCREENING PANEL DID NOT REACT WITH THE S HOMOZYGOUS CELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
986842	SEARCH-CYTE TCS 0.8%	BLOOD GROUPING REAGENT	KSZ	MEDION GRIFOLS DIAGNOSTICS AG	SEARCH-CYTE TCS 0.8%	644715010

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR		Other