FDA.reportPublic FDA data

MAUDE MDR 226688

MDR report key
226688
Report number
1219913-1999-00001
Event key
0
Event type
3
Date received
1999-05-26
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#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACS:180 THEOPHYLLINEIMMUNOASSAYBAYER DIAGNOSTICSLGSNA672285, 672286ALL LOTSK951169N*Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11999-05-260

Event Narratives#

D

Patient 1

INITIAL FIELD REPORTS RECEIVED IN 1/99 SUGGESTED LOW CONTROL RECOVERIES OF THE ACS:180 THEOPHYLLINE ASSAY RESULTING IN AN INTERNAL INVESTIGATION. INITIAL STUDIES WERE INCONCLUSIVE. SUBSEQUENT INTERNAL TESTING REPORTED IN APRIL 1999 INDICATED THAT CERTAIN ACS:180 ASSAYS WHEN RUN IN RANDOM ACCESS WITH ACS:180 THEOPHYLLINE CAUSED DEPRESSED THEOPHYLLINE VALUES. THE SHIFT IN VALUES CAN BE SUMMARIZED AS FOLLOWS: ASSAY - CKMB, EFFECT ON THEO - -5 TO -10%; ASSAY - DIGOXIN, EFFECT ON THEO - -3% TO -10%; ASSAY - PRGE, EFFECT ON THEO - -3% TO -5%; ASSAY - GI, EFFECT ON THEO - -3% TO -8%; ASSAY - LH2, EFFECT ON THEO - -5% TO -7%; ASSAY - CKMB II, EFFECT ON THEO - -12% TO -20%; ASSAY - ESTRADIOL, EFFECT ON THEO - -6%; ASSAY - T4, EFFECT ON THEO - -3% TO -13%; AND ASSAY - TSH3, EFFECT ON THEO - -2% TO -6%. THE ACS:180 THEOPHYLLINE ASSAY CONTINUES TO MEET ITS PERFORMANCE CLAIMS WHEN RUN IN BATCH MODE. THERE WERE NO ADVERSE EVENTS INCLUDING SERIOUS INJURIES OR DEATHS ASSOCIATED WITH THIS EVENT.