VITROS 5600 INTEGRATED SYSTEM 6801042

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-23 for VITROS 5600 INTEGRATED SYSTEM 6801042 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[78397230] The investigation determined that lower than expected myoglobin results were obtained from two levels of biorad quality control fluids processed using vitros myoglobin reagent on a vitros 5600 integrated system. The most likely assignable cause is instrument related. A review of historical biorad qc fluid performance across two vitros 5600 systems in the laboratory concluded that myoglobin imprecision was occurring on only one vitros system suggesting that the issue is most likely instrument and not reagent related. An ortho field engineer performed service actions that include replacement of the reagent metering probe and adjustments in several subsystems. Following these actions, acceptable within run myoglobin precision results were obtained. In addition, acceptable biorad qc performance was maintained indicating the vitros 5600 system was performing as expected following service actions.
Patient Sequence No: 1, Text Type: N, H10

[78397231] The investigation determined that lower than expected myoglobin results were obtained from two levels of non-vitros biorad lot 23630 quality control fluids processed using vitros immunodiagnostics products myoglobin reagent lot 1210 on a vitros 5600 integrated system. Biorad level 1= 101. 4, 89. 63, 113. 46, 110. 188, 116. 413, 113. 041, 118. 559, 78. 998, 82. 18, 109. 92, 116. 995, 95. 58, 93. 59, 96. 5, 96. 312, 82. 75, 84. 98 and 96. 67 ng/ml versus expected 131 ng/ml. Biorad level 2= 0. 90 and 91. 096 ng/ml versus expected 251 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The unexpected vitros myoglobin results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1319681-2017-00047
• MDR Report Key: 6662840
• Date Received: 2017-06-23
• Date of Report: 2017-06-23
• Date of Event: 2017-05-28
• Date Mfgr Received: 2017-05-28
• Device Manufacturer Date: 2017-01-04
• Date Added to Maude: 2017-06-23
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. JAMES A STEVENS
• Manufacturer Street: 100 INDIGO CREEK DRIVE
• Manufacturer City: ROCHESTER NY 14626
• Manufacturer Country: US
• Manufacturer Postal: 14626
• Manufacturer Phone: 5854533000
• Manufacturer G1: ORTHO-CLINICAL DIAGNOSTICS
• Manufacturer Street: 100 INDIGO CREEK DRIVE
• Manufacturer City: ROCHESTER NY 14626
• Manufacturer Country: US
• Manufacturer Postal Code: 14626
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Generic Name: CHEMISTRY ANALYZER
• Product Code: DDR
• Date Received: 2017-06-23
• Catalog Number: 6801042
• Device Expiration Date: 2017-11-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
• Manufacturer Address: 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626

Device Sequence Number: 1

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Generic Name: CHEMISTRY ANALYZER
• Product Code: JJE
• Date Received: 2017-06-23
• Catalog Number: 6801042
• Device Expiration Date: 2017-11-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
• Manufacturer Address: 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-06-23