BERICHROM HEPARIN 10446620

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 2017-12-27 for BERICHROM HEPARIN 10446620 manufactured by Siemens Healthcare Diagnostics Products Gmbh.

Event Text Entries

[95905511] A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer's site to determine the cause of the discordant, falsely low heparin unfractionated (uf) result and quality control (qc) imprecision on the sysmex ca-1500 system. The cse observed a crack on the edge of the optical filter on the sysmex ca-1500 system and replaced the optical filter. The cse also verified the z adjustment on the piercer at the feeder position, verified that the lamp unit #3 box was internally clean, removed and cleaned filters, cleaned fiber end, verified the lamp stability, during the lamp calibration, with water in the 4 cuvettes, adjusted the reagent dispenser to the right of the center in the reaction vessel and lowered the reagent dispenser to miss the spring on catcher by 1 to 2 mm. After replacing the optical filter and performing the adjustments on the sysmex ca-1500 system, the cse ran calibration, qc, and performed three precision studies using control level 1, control level 2 and patient samples. The calibration, qc and precision studies recovered within expected ranges in micro mode and outside of expected ranges in normal mode. The operator declined further investigation and stopped running the heparin uf assay. The filter malfunction potentially contributed to the discordant result and qc imprecision. No further evaluation of these systems or reagent is required.
Patient Sequence No: 1, Text Type: N, H10


[95905512] Imprecise and out of range heparin unfractionated (uf) quality control (qc) results were obtained on the sysmex ca-1500 system. During this time, a patient sample was tested for heparin uf, resulting in a discordant, falsely low heparin uf result. This result was reported to the physician, who did not question the result. The patient's blood was redrawn and run on an alternate system, sysmex ca-1500 system, using same reagent lot. A higher heparin uf result, within therapeutic range, was obtained using the alternate system. It is unknown if the redrawn result was the correct result as the operator was also experiencing issues with the alternate system. The operator indicated that a corrected report was provided for this patient as the pharmacy indicated that the patient was on heparin treatment when the discordant result was reported. However, the corrected result is unknown. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin uf result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610806-2017-00151
MDR Report Key7149214
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-12-27
Date of Report2018-02-02
Date of Event2017-12-01
Date Mfgr Received2018-01-08
Date Added to Maude2017-12-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCHRISTINA LAM
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145243504
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer StreetEMIL-VON-BEHRING- STR. 76
Manufacturer CityMARBURG, D-35041
Manufacturer CountryGM
Manufacturer Postal CodeD-35041
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBERICHROM HEPARIN
Generic NameBERICHROM HEPARIN
Product CodeKFF
Date Received2017-12-27
Model NumberBERICHROM HEPARIN
Catalog Number10446620
Lot Number47293
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Manufacturer AddressEMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-27

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