HACH STERICHEK TOTAL CHLORINE REAGENT STRIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-22 for HACH STERICHEK TOTAL CHLORINE REAGENT STRIPS manufactured by Hach Company.

Event Text Entries

[17492149] Thirty three pts involved. See attached pages 3 & 4. In 2008, a facility nurse reviewing routine weekly lab results for the facility's dialysis pts noted a drop in hemoglobin for approx 33 pts. The relevant labs are included on p4, for each pt. On the same day, another facility staff noted a possible discoloration of the dialysis lines. The facility immediately discontinued all pt treatments and initiated an investigation, which revealed a suspected chlorine break-through in the facility's water purification system. Hach test strips used to detect chlorine had given false negative readings. The facility's investigation revealed three bottles that were not reactive to chlorine. The bottles originated from lot #s 7163 and 7044. We believe 33 pts were admitted to the hosp throughout the last 14 days. Most of whom were reportedly diagnosed with anemia. At least one pt was reportedly diagnosed with hemolytic anemia and myocardial infarction. Lot#-7044, expiration date-12/2008. See scanned pages.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1048132
MDR Report Key1048132
Date Received2008-05-22
Date of Report2008-05-14
Date of Event2008-04-30
Date Facility Aware2008-04-30
Report Date2008-05-14
Date Reported to FDA2008-05-14
Date Reported to Mfgr2008-05-14
Date Added to Maude2008-06-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHACH STERICHEK TOTAL CHLORINE REAGENT STRIPS
Generic NameSTRIP/TEST/REAGENT/RESIDUAL FOR DIALYSIS
Product CodeMSY
Date Received2008-05-22
Lot Number7163
Device Expiration Date2009-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 YR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1025898
ManufacturerHACH COMPANY
Manufacturer AddressAMES IA US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2008-05-22

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