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

Catalog Number 8546733

Device Problems High Test Results (2457); Device Displays Incorrect Message (2591); Device Ingredient or Reagent Problem (2910)

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

Event Date 03/04/2014

Event Type  malfunction  

Event Description

The customer reported hemoglobin (hgb) background was recovering high when using the coulter hmx hematology analyzer with autoloader.The instrument generated voltage (vdc - volts direct current) errors.There were no erroneous test results associated with this event.There was no death, injury or affect to the user or patient associated with this event.

Manufacturer Narrative

On (b)(4) 2014, the field service engineer (fse) evaluated the analyzer and confirmed the hemoglobin (hgb) background would only recover high when performing a "repeat background test" or "system test".The fse determined the white blood cell (wbc) bath housing in the hgb read area was discolored.The fse replaced the wbc bath housing resolving the high hgb background counts and voltage errors.(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 and m405237 through m503553.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 from k010765 to exempt to correlate to the product.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: COUNTER, BLOOD CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 7381 empire dr; florence KY 41042
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-s08; miami, FL 33196 ; 3053802031
• MDR Report Key: 3704630
• MDR Text Key: 4338154
• Report Number: 1061932-2014-00684
• 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: 03/04/2014

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
• Other Device ID Number: 1.3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2005
• 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