ACL 3000 0110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-01 for ACL 3000 0110 manufactured by Instrumentation Laboratories, Inc..

Event Text Entries

[19233] The customer reported to co that the instrument failed to display any warning when it was out of calcium chloride reagent. An erroneous result was then reported out and caused a physician to adjust the pt's heparin therapy. The customer attributed the failure to a needle block sensor failure. The customer reported the incident to customer svc by telephone fourteen (14) days later. Co's investigation revealed that the customer svc specialist (css) visited the account the day after the incident and as corrective action, replaced the suspected defective needle block and then verified that the unit was operating to mfr spec. The mfr's investigation indicated that testing was not performed on the suspected component before it was replaced and disposed of. Due to the delay by the customer in filing the incident report, it was not possible to retrieve the part. Both co technical support and the mfr concurred that the failure, as described by the customer, was highly unusual and very difficult to reconcile. The mfr states that repeated sensor errors would be expected following the initial sensor failure yet this was not observed. The possibility of a bubble in the sample cup can not be ruled out as a cause of the erroneous results. The printout tape supplied by the customer contained a "not coag" message. This message occurs if the sample was not delivered to the reaction cuvette. Due to the unavailability of the suspect needle block, as well as the absence of sensor errors after the suspect component was tested, it is not possible to assign a root cause related to the instrument or rule out operator error.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1023939-1995-00003
MDR Report Key28291
Date Received1995-10-21
Date of Report1995-10-20
Date of Event1995-09-22
Date Facility Aware1995-10-05
Report Date1995-10-20
Date Reported to FDA1995-10-20
Date Reported to Mfgr1995-10-11
Date Added to Maude1995-12-01
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameACL 3000
Generic NameCOAGULATION INSTRUMENT
Product CodeKQG
Date Received1995-12-01
Model Number0110
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key29219
ManufacturerINSTRUMENTATION LABORATORIES, INC.
Manufacturer Address101 HARTWELL AVE KENSINGTON MA 02173 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1995-10-21

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