FDA.reportPublic FDA data

MAUDE MDR 1588030

MDR report key
1588030
Report number
1215667-2010-00001
Event key
0
Event type
3
Date of event
2009-12-15
Date received
2010-01-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
TINA LOMBARI
Address
14 ALMEIDA AVE EAST PROVIDENCE RI 02914 US
Phone
401-401-4018
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WAMPOLE LABORATORIES STAPH LATEX KITNERL DIAGNOSTICS, LLCJWX56D60919119Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-01-1501. O

Event Narratives#

D

Patient 1

ON (B)(6) 2009, IT WAS CONFIRMED THAT THE STAPH LATEX REAGENT WAS NOT SUFFICIENTLY REACTIVE WITH THE RECOMMENDED POSITIVE CONTROL. THE STAPH LATEX KIT IS A LATEX AGGLUTINATION KIT IN WHICH THE REAGENT SHOULD AGGLUTINATE WHEN TESTED WITH A KNOWN POSITIVE CONTROL ORGANISM (B)(6). WHEN THE KITS IN QUESTION WERE TESTED WITH THE POSITIVE CONTROL, AS RECOMMENDED IN THE PACKAGE INSERT, WEAKENED AGGLUTINATION WAS OBSERVED.

N

Patient 1

ADD'L LOT # 1110049. IN RESPONSE TO THE RECEIPT OF THESE COMPLAINTS, WE CONDUCTED AN INVESTIGATION. BOTH OF THESE LOTS WERE MANUFACTURED FROM THE SAME BULK LOT OF STAPH LATEX REAGENT. WE REPEATED QUALITY CONTROL RELEASE TESTING ON RETENTION KITS AS WELL AS RETURNED KITS. OUR TESTING INDICATED REDUCED REACTIVITY (OUT OF SPECIFICATION) OF THE LATEX REAGENT IN THE PRESENCE OF THE RECOMMENDED POSITIVE CONTROL. BASED ON THESE RESULTS, WE CONDUCTED A RISK ASSESSMENT. A DECISION WAS MADE TO RECALL BOTH LOTS OF PRODUCT WHICH WERE SHIPPED TO ONE DISTRIBUTOR. WE ARE WORKING WITH THAT DISTRIBUTOR TO ENSURE THAT ALL END USERS ARE NOTIFIED OF THE RECALL. A SAMPLE LETTER TO THE DISTRIBUTOR IS ATTACHED. IN ADDITION, TO ENSURE THAT THIS PRODUCT MALFUNCTION DOES NOT RECUR, THE FOLLOWING MEASURES WERE TAKEN. THE SOP FOR STOCK CULTURE MAINTENANCE (B)(4) HAS BEEN UPDATED TO INCLUDE THE ORGANISMS UTILIZED FOR THE QC BULK AND RELEASE TESTING FOR THE STAPH LATEX KIT. APPROPRIATE QC PERSONNEL HAVE BEEN TRAINED TO THE NEW REVISION (B)(4).