MAUDE Adverse Event Report: MICROTYPING SYSTEMS BLOOD GROUPING REAGENT MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD; MTS GEL CARDS - BLOOD GROUPING REAGENTS

Catalog Number MTS080515

Device Problem False Positive Result (1227)

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

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot and master lot.Based upon the results of this investigation, the reported customer issue was unable to be confirmed.All results were satisfactory.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Event 1 of 3.Account reporting possible false positive results with abd/reverse card lot 011019037-17 in the forward d(rh) typing with 3 patient samples.Customer last reported that 3 patients (1 in the last 2 weeks) and 2 earlier in the year, where forward d typing was originally 3+ but all patients later developed anti-d.Account also performed tube typing on the patients using ortho's anti-d bioclone (lot number not provided) and all three patients were is d negative, weak d positive.Issue started on: reported(b)(6) 2019.Microtubes/wells or cell (donor #) affected: forward d typing.Reaction grade obtained: 3+ customer was expecting: negative.Incubation time (for manual test only): unknown at this time.Test repeated: account only repeated vision results in manual gel.Method/result obtained by repeating: weak d positive.Daily qc performed and found to be acceptable.Product handling protocol: cassette/gel card storage temperature range: per ifu.Cassette/gel card orientation: upright.Rbc storage and handling: per ifu.Visual appearance before use: all reagents have a normal appearance prior to use.Opened vs unopened? unopened.Tsc explained to account that it is possible for a rh postive patient to form anti-d if they are missing part of the d antigen.Clones are different in gel vs tube reagents.31jul2019-followed up with customer: one patient was a (b)(6) female that was pregnant.Account typed her as b positive.She received rh positive units on (b)(6) 2019.On (b)(6) 2019 she displayed anti-d.Weak d reactivity with bioclone was 3+.Account denies that she received rhogam.Patient received transfusion as she has sickle cell anemia.02aug2019-followed up with account - second patient - female previously typed as a pos was sent to a reference lab due to the fact that they detected anti-d in the sample.Report came back as auto anti-d and anti-c.This was in (b)(6).Patient represented on (b)(6) 2019 with the auto anti-d still showing.Patient had received 6 rh positive units in (b)(6) 2018.A neighboring hospital called them for history.In their hands patient was rh negative with immucor echo.However, this account is still seeing 3+ positive on the vision with gel.Bioclone tube testing was weak d (b)(6) 2019- followed up with account.Third patient.(b)(6) pregnant female previously typed with tube as rh negative.Account received 3+ positive in gel on the vision.Sample was sent for molecular testing and came back as a partial d.Account is considering redoing their policy for how to handle rh positive women of child bearing age.Tss reviewed with account again that most likely cause of discrepancies noted are differences in clones used in commercial reagents.They all target a different portion of the d antigen.Account satisfied with explanation.

• Brand Name: BLOOD GROUPING REAGENT MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD
• Type of Device: MTS GEL CARDS - BLOOD GROUPING REAGENTS
• Manufacturer (Section D): MICROTYPING SYSTEMS; 1295 southwest 29th avenue; pompano beach FL 33069
• Manufacturer (Section G): MICROTYPING SYSTEMS; 1295 southwest 29th avenue; pompano beach FL 33069
• Manufacturer Contact: james a stevens ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 8903846
• MDR Text Key: 218540575
• Report Number: 1056600-2019-00030
• Device Sequence Number: 1
• Product Code: KSZ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: MTS080515
• Device Lot Number: 011019037-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1