MAUDE Adverse Event Report: BECKMAN COULTER, INC. NEG URINE COMBO PANEL TYPE 62; MICRO DILUTION PANEL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

The neg urine combo panel type 62 (nuc62) data was reviewed by beckman national product support team.The biotypes differed by the ara reaction.The initial read was ara negative resulting in the low probability identification.The repeat was ara positive providing the correct id at 99%.In comparing the processed values for all the biochemical reactions, the initial panel had values that averaged 10 - 20% lower than the repeat panel; the ara value was 3x lower.The trimethoprim/sulfamethoxazole (t/s) on the initial read had a value indicating activity in the well, however it was not enough to go over the 80% rule algorithm and was considered susceptible.The repeat had considerably more growth in the well and did go over the threshold.It is suspected the initial panel was slightly under inoculated or the organism viability was not optimal due to age of the culture or limited number of passes.The failure mode for the reported misidentification and false susceptible t/s result was user error.The initial panel testing obtained a low probability yersinia identification and a susceptible t/s result.The customer reported out the low probability identification (lpid) and susceptible t/s result out to the physician prior to confirming the identification.Upon repeat testing, the customer obtained the correct high probability identification and resistant t/s result.Data indicated the initial test panel was likely under-inoculated, resulting in the lpid and susceptible t/s result.There is insufficient evidence of an instrument or panel malfunction as instrument and panel qc were in range and the correct id and drug interpretation were obtained on the nc62 panel.

Event Description

It was reported that the customer tested the isolate on neg urine combo panel type 62, lot 2017-04-04 on (b)(6) 2016.The panel obtained a low probability identification of yersinia ruckeri 82.34%, biotype (b)(6).The customer reported the id to the physician as yersinia species prior to receiving the confirmatory test result from the reference laboratory.On (b)(6) 2016, the customer received the reference lab result as shigella sonnei and an amended report was sent to the physician on (b)(6) 2016.On (b)(6) 2016, the customer reported that repeat testing was performed and the correct identification of shigella sonnei, biotype (b)(6) was obtained.It was further reported that the customer reviewed the susceptibilities and indicated that initial testing had trimethoprim/ sulfamethoxazole (t/s) as susceptible but upon repeat, it was resistant.The reference lab reported t/s as resistant as well.The customer notified the nurse and the nurse informed the customer that the patient was prescribed t/s but had not actually taken it.On (b)(6) 2016 the customer reported that the attending nurse indicated the patient would be prescribed an alternative antibiotic however specific details were not provided.

• Brand Name: NEG URINE COMBO PANEL TYPE 62
• Type of Device: MICRO DILUTION PANEL
• Manufacturer (Section D): BECKMAN COULTER, INC.; 2040 enterprise blvd; west sacramento CA 95691
• Manufacturer (Section G): BECKMAN COULTER INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer Contact: elizabeth church ; 1584 enterprise blvd; west sacramento, CA 95691 ; 9163742457
• MDR Report Key: 5820676
• MDR Text Key: 50389880
• Report Number: 2919016-2016-00004
• Device Sequence Number: 1
• Product Code: LQM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 04/04/2017
• Device Model Number: N/A
• Device Catalogue Number: B1017-416
• Device Lot Number: 2017-04-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR