MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS GLU SLIDES; IN-VITRO DIAGNOSTIC

Catalog Number 1707801

Device Problem High Readings (2459)

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

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined the higher than expected vitros glu results were obtained for multiple quality control fluids and patient samples run on a vitros 5600 integrated system.The assignable cause of the event is unknown, however, the most likely assignable cause is a non-reactive cartridge caused by having the integrity of the foil wrapper compromised and exposing the slides to ambient conditions, although this could not be confirmed.For the vitros glu assay, a non-reactive cartridge causes higher than expected results.Acceptable glu results were obtained when the same samples were tested with an alternate vitros glu slide lot 0030-0918-2862 cartridge, and quality control results processed on alternate vitros glu slide lot 0030-0918-2862 cartridges prior to, and after the event were acceptable.This would indicate the event was isolated to the affected vitros glu slide lot 0030-0918-2862 cartridge in use at the time of the event.

Event Description

The customer obtained higher than expected vitros glu results for multiple quality control fluids and patient samples run on a vitros 5600 integrated system.Biorad multiqual control lot 15950 l1 result of 196.9 mg/dl vs.The expected result of 60.0 mg/dl.Biorad multiqual control lot 15950 l3 result of 579 mg/dl vs.The expected result of 338 mg/dl.Biorad spinal fluid control 55660 l2 result of 180.3 mg/dl vs.The expected result of 29.6 mg/dl.Patient sample 1 result of 294 mg/dl vs.The expected result of 132 mg/dl.Patient sample 2 result of 474 mg/dl vs.The expected result of 254 mg/dl.Patient sample 3 result of 257 mg/dl vs.The expected result of 104 mg/dl.Patient sample 4 result of 262 mg/dl vs.The expected result of 108 mg/dl.Patient sample 5 result of 509 mg/dl vs.The expected result of 271 mg/dl.Patient sample 6 result of 322 mg/dl vs.The expected result of 152 mg/dl.Patient sample 7 result of 243 mg/dl vs.The expected result of 94 mg/dl.Patient sample 8 result of 301 mg/dl vs.The expected result of 139 mg/dl.Patient sample 9 result of 221 mg/dl vs.The expected result of 78 mg/dl.Patient sample 10 result of 339 mg/dl vs.The expected result of 153 mg/dl.Patient sample 11 result of 254 mg/dl vs.The expected result of 104 mg/dl.Patient sample 12 result of 257 mg/dl vs.The expected result of 105 mg/dl.Patient sample 13 result of 252 mg/dl vs.The expected result of 99 mg/dl.Patient sample 14 result of 292 mg/dl vs.The expected result of 132 mg/dl.Patient sample 15 result of 222 mg/dl vs.The expected result of 75 mg/dl.Patient sample 16 result of 248 mg/dl vs.The expected result of 97 mg/dl.Patient sample 17 result of 252 mg/dl vs.The expected result of 100 mg/dl.Patient sample 18 result of 233 mg/dl vs.The expected result of 77 mg/dl.Patient sample 19 result of 260 mg/dl vs.The expected result of 104 mg/dl.Patient sample 20 result of 217 mg/dl vs.The expected result of 72 mg/dl.Patient sample 21 result of 296 mg/dl vs.The expected result of 132 mg/dl.Patient sample 22 result of 424 mg/dl vs.The expected result of 219 mg/dl.Patient sample 23 result of 245 mg/dl vs.The expected result of 95 mg/dl.Patient sample 24 result of 326 mg/dl vs.The expected result of 155 mg/dl.Patient sample 25 result of 229 mg/dl vs.The expected result of 104 mg/dl.Patient sample 26 result of 281 mg/dl vs.The expected result of 119 mg/dl.Patient sample 27 result of 251 mg/dl vs.The expected result of 69 mg/dl.Patient sample 28 result of 261 mg/dl vs.The expected result of 105 mg/dl.Patient sample 29 result of 293 mg/dl vs.The expected result of 126 mg/dl.Patient sample 30 result of 244 mg/dl vs.The expected result of 91 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The affected results were reported outside the laboratory; however, a corrected report was issued once repeat testing was complete.There was no allegation of patient harm as a result of this event.This report is number 27 of 33 mdr's for this event.Thirty-three (33) 3500a forms are being submitted for this event as 33 devices were involved.This report corresponds to ortho clinical diagnostics inc.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 6710047
• MDR Text Key: 80269148
• Report Number: 1319809-2017-00125
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Catalogue Number: 1707801
• Device Lot Number: 0030-0918-2862
• Other Device ID Number: 10758750009572
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1