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

Catalog Number 8546733

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

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 01/02/2014

Event Type  malfunction  

Event Description

A customer called reporting she was experiencing hgb background failures on their hmx instrument.No erroneous results were associated with this event.

Manufacturer Narrative

A field service engineer (fse) was dispatched.The fse noticed that the bottom of wbc bath was very cloudy.He replaced the wbc bath.After installation of new wbc bath, hgb background passed (hgb is read in the wbc bath).Upon recur of the failure mode, erroneous hgb results could be generated due to optical failure from film buildup or contamination.(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 under suspect 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 to serious injury or death as the probability of harm per the risk assessment is highly unlikely and not a reportable event.

• Brand Name: COULTER ISOTON III 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 dr; florence KY 41042
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 3594123
• MDR Text Key: 4141664
• Report Number: 1061932-2014-00226
• 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: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/03/2014

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: 8546733
• Device Lot Number: 50793F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2014
• Initial Date FDA Received: 01/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2001
• 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