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 11/19/2014

Event Type  malfunction  

Event Description

Customer reported the hemoglobin test results for the abnormal level ii control were elevated outside of range, and the other two levels of control were within range but shifting toward the upper limit, when using the coulter lh 500 hematology analyzer in their laboratory.The customer reported that this was an on-going issue.The customer also reported differential test results were not generated.A beckman coulter field service engineer was sent to the customer's facility to evaluate the analyzer.The fse identified cloudy build-up inside the white blood cell (wbc) aperture housing and replaced the part.There were no erroneous patient test results associated with this event.There was no death, injury or affect to user or patient treatment.

Manufacturer Narrative

On (b)(4) 2014, a beckman coulter field service engineer (fse) evaluated the analyzer and replaced the white blood cell (wbc) bath to resolve the hemoglobin and differential issues reported.There were no further issues observed and results were recovering within range.(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 is listed; 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; (b)(4).The manufacturing site address has been updated to correlate to the product, new information about the root cause was completed on 8/12/2015.Root cause changed the 510k to exempt to correlate to the product.Method, results and conclusion codes changed based on root cause; patient and product codes added, as the fields in the 3500a form have been updated since the initial report.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: 4331207
• MDR Text Key: 19761674
• Report Number: 1061932-2014-03034
• 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: 11/19/2014

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
• Other Device ID Number: SOFTWARE VERSION: 2A6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• 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