MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK; IN-VITRO DIAGNOSTIC

Catalog Number 1912997

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined higher than expected vitros tsh results were obtained from a single (b)(6) proficiency sample tested on three different vitros 5600 integrated systems.A definitive assignable cause for the higher than expected vitros tsh (b)(6) proficiency sample results could not be determined.Based on historical quality control results, a vitros tsh lots 5570 and 5610 performance issue is not a likely contributor to the event.There is also no indication of any instrument malfunction and unexpected instrument performance is not a likely contributor to the events.The most likely assignable cause for the higher than expected vitros tsh results for (b)(6) is the condition of the sample itself as the sample was reported by the customer to be greenish in color.Additionally, storage and handling of the sample cannot be ruled out as a contributing factor.

Event Description

The customer obtained higher than expected vitros tsh results on a proficiency sample from (b)(6) on three different vitros 5600 integrated systems when compared to the target mean result obtained from the (b)(6) linearity survey.(b)(6) results of 0.506, 0.537, 0.54, 0.564 and 0.499 miu/l vs.The expected result of 0.378 miu/l biased results of the direction and magnitude observed could lead to inappropriate physician action.The higher than expected vitros tsh (b)(6) proficiency sample results were from non-patient fluids and were not reported to the proficiency provider.There was no indication that patient samples were affected, however, the investigation could not conclude patient samples were not affected or would not be affected if the event were to recur undetected.This report is number two of two 3500a forms filed for this event, as two devices were affected.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7558326
• MDR Text Key: 110384416
• Report Number: 3007111389-2018-00071
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2018
• Device Catalogue Number: 1912997
• Device Lot Number: 5610
• Other Device ID Number: 10758750000227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1