IQ200 AUTOMATED URINALYSIS SYSTEM 700-3347

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-06-09 for IQ200 AUTOMATED URINALYSIS SYSTEM 700-3347 manufactured by Iris International.

Event Text Entries

[47202867] The customer sent a disc containing instrument information and audit trail to bec, and it was received on 06/08/2016. Further information will be provided upon completion of data analysis. The cause of the event is currently unknown. Bec internal identifier for this report is (b)(6). The patient's date of birth was redacted by the customer; the patient's weight was not provided by the customer.
Patient Sequence No: 1, Text Type: N, H10


[47202868] The customer reported they ran sample id # (b)(6) in rack 4, position 1 on a iq200 automated urinalysis system and it came up on the screen with correct demographics and correct id # ((b)(6)). However, when the customer selected accept on the screen, the instrument reportedly printed results with id # (b)(6) but with correct patient demographics and results. The id # (b)(6) had been run the day before on the same rack and same position. The customer checked manual orders and there were no manual orders that had been entered or failed to be cleared. The customer repeated analysis of sample id # (b)(6) using rack 5, position 1 and all information was reported and printed correctly. The misidentified patient results were not reported out of the laboratory and there was no change or effect to patient treatment in connection to the event.
Patient Sequence No: 1, Text Type: D, B5


[50751007] A backup disk from the customer was returned to beckman coulter, which was analyzed by the applications team. The analysis revealed that a problem occurred when sample (b)(6) was originally run, causing the chemistry portion to be separated from the microscopy section. When this separation of result segments occurs, if all result segments are not either deleted or consolidated properly, it will lead to future problems. The objective evidence of an error with separation is the sequence number for the original result which was zero (0) and was revealed when the system backup was reviewed. This sequence number only occurs when the chemistry and microscopy are broken apart. Additionally, the record shows that the specimen id was changed by the operator at this time. Analysis was unable to determine why the sample analysis stamp date is different than the verification dates. The root cause is unknown and inconclusive.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2023446-2016-00273
MDR Report Key5710664
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-06-09
Date of Report2016-05-17
Date of Event2016-05-17
Date Mfgr Received2016-07-15
Device Manufacturer Date2015-05-28
Date Added to Maude2016-06-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactGOPAL MOHANTY
Manufacturer Street9172 ETON AVENUE
Manufacturer CityCHATSWORTH, CA CA 91311
Manufacturer CountryUS
Manufacturer Postal91311
Manufacturer Phone8185277379
Manufacturer G1IRIS INTERNATIONAL
Manufacturer Street9172 ETON AVE
Manufacturer CityCHATSWORTH CA 91311
Manufacturer CountryUS
Manufacturer Postal Code91311
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameIQ200 AUTOMATED URINALYSIS SYSTEM
Generic NameCOUNTER, URINE PARTICLE
Product CodeLKM
Date Received2016-06-09
Model NumberNA
Catalog Number700-3347
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerIRIS INTERNATIONAL
Manufacturer Address9172 ETON AVE CHATSWORTH CA 91311 US 91311


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-09

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