IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK 6801042

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[131340968] The investigation concluded that multiple lower than expected vitros myog quality control results and multiple higher than expected vitros ckmb quality control results were obtained using non-vitros biorad quality control fluids in combination with a vitros 5600 integrated system. The assignable cause for the higher and lower than expected biorad qc fluid results could not be determined with the information provided by the customer. There was no evidence to suggest a vitros 5600 integrated system malfunction; however, it cannot be entirely ruled out as a contributing factor as the same quality control fluids generated acceptable results on an alternate vitros eci system on site. Additionally, based on multiple historical vitros reagent quality control results, and since the same reagent lots generated acceptable quality control results on an alternate vitros eci system, there is no indication a reagent related issue contributed to the event. Continual tracking and trending of complaints has not identified any signals that would point to potential systemic issues with vitros product ckmb, lot 2370 or myog lot 1365. Finally, it is unlikely a biorad quality control sample related issue as the same control fluids generated acceptable results on an alternate vitros eci system.
Patient Sequence No: 1, Text Type: N, H10


[131340969] The investigation has determined that higher than expected vitros ckmb results were obtained from non-vitros biorad l1 qc fluid using vitros immunodiagnostics product ck-mb reagent on a vitros 5600 integrated system and lower than expected vitros myog results were obtained from a non-vitros biorad qc fluid using vitros immunodiagnostics product myoglobin reagent on a vitros 5600 integrated system. Biorad cardiac marker plus lot 23690 l1 qc fluid (ckmb) results of 4. 81, 4. 81, 4. 79, 4. 81 and 4. 87 ng/ml versus the expected result of 3. 026 ng/ml. Biorad cardiac marker plus lot 23690 l1 qc fluid (myog) results of 68. 49, 70. 30, 72. 68, 74. 55, 94. 93, 98. 74, 99. 25, 99. 81, 101. 83, 101. 83, 102. 72, 103. 78, 104. 04, 106. 31, 107. 05, 110. 14, 111. 28, 111. 48, 112. 23, 112. 62, 113. 0, 113. 98, 114. 38, 114. 43, 114. 93, 115. 84, 116. 55, 117. 28, 117. 92, 118. 42, 118. 89, 119. 31, 119. 85 and 120. 28 miu/ml versus the expected result of 131. 6 miu/ml. A biased result of the direction and magnitude observed may lead to inappropriate physician action if it were to occur undetected with patient samples. Ortho has not been made aware of any erroneous vitros myog or ckmb patient sample results obtained or reported from the laboratory over the time frame of the event; however, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. This report is number two of two 3500a forms filed for this event, as two devices were affected. This report corresponds to ortho clinical diagnostics (ortho). Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007111389-2018-00199
MDR Report Key8189986
Date Received2018-12-21
Date of Report2018-12-21
Date of Event2018-12-02
Date Mfgr Received2018-12-02
Device Manufacturer Date2018-05-31
Date Added to Maude2018-12-21
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 ContactMR. JAMES A STEVENS
Manufacturer Street100 INDIGO CREEK DRIVE
Manufacturer CityROCHESTER NY 14626
Manufacturer CountryUS
Manufacturer Postal14626
Manufacturer Phone5854533000
Manufacturer G1ORTHO CLINICAL DIAGNOSTICS
Manufacturer StreetFELINDRE MEADOWS PENCOED
Manufacturer CityBRIDGEND, WALES CF355PZ
Manufacturer CountryUK
Manufacturer Postal CodeCF35 5PZ
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameIMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK
Generic NameIN-VITRO DIAGNOSTIC
Product CodeDDR
Date Received2018-12-21
Catalog Number6801042
Lot Number1365
Device Expiration Date2019-05-02
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-21

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