FDA.reportPublic FDA data

MAUDE MDR 4528273

MDR report key
4528273
Report number
MW5040773
Event key
0
Event type
3
Date received
2015-02-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACL ELITECOAGULATION INSTRUMENTINSTRUMENTATION LABORATORY COJKP

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-02-1101. R

Event Narratives#

D

Patient 1

CHANGES IN LABORATORY VALUES. EQUIPMENT TAKEN OUT OF SERVICE AND MANUFACTURER CONTACTED FOR THE TROUBLESHOOTING. SERVICE COMPLETED ON (B)(6) 2015. THE SAMPLE BLOCK ASSEMBLY WAS REPLACED AND EQUIPMENT RETURNED TO SERVICE AT THAT TIME. NO APPARENT LONG-TERM ADVERSE EFFECT FOR THE PATIENTS.