MAUDE Adverse Event Report: BECKMAN COULTER COULTER ISOTON 4 DILUENT; DILUENT, BLOOD CELL

Catalog Number 8547148

Device Problems High Test Results (2457); Device Ingredient or Reagent Problem (2910)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

The customer reported that the hemoglobin (hgb) was high on 5c quality controls (qc) run on a coulter lh 500 hematology analyzer.In addition, the customer reported that there had been high hgb on startup.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument on (b)(4) 2015.The fse indicated that he observed hgb high on startup; however the results were within specification.The hgb voltage was also unstable.He cleaned the white blood cell (wbc) bath with a bleach solution; however, the problem persisted.The wbc bath holds wbc dilution for mixing and for collection of wbc and hgb data.The wbc bath was still cloudy after cleaning and was replaced to resolve the qc, background, and hgb voltage issues reported.(b)(4).

Manufacturer Narrative

Based on root cause, the suspect product was identified to be the reagent(s) used with the instrument.The first product; subsequent products are provided here; it is unknown which lots were in use at the time of the event.Therefore, expiration date and device manufacturing date are also unknown for this event.Brand name: coulter isoton iii diluent; catalog #: 8546733; lot #: 50793f through 50818f.Brand name: coulter isoton 4 diluent; catalog #: 8547148; lot #: 18206f.Brand name: coulter lh series diluent; catalog #: 8547194; lot #: 510409f through 510657f; m405237 through m503553.New information about the root cause was completed on 8/12/2015.A recall was completed and an important product notice letter was sent to customers on 09/09/2015.The root cause has been identified as lot to lot variation in the sodium sulfate used in the reagent, which resulted in a compromised white blood cell (wbc) bath in this event.In addition, the investigation found that the root cause identified would not cause or contribute.

• Brand Name: COULTER ISOTON 4 DILUENT
• Type of Device: DILUENT, BLOOD CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN_COULTER; 7381 empire drive; florence KY 41042
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 4492285
• MDR Text Key: 5345886
• Report Number: 1061932-2015-00201
• Device Sequence Number: 1
• Product Code: GIF
• 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 Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/09/2015

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 Catalogue Number: 8547148
• Device Lot Number: 18206F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 02/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1