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

Catalog Number 8547148

Device Problems Device Ingredient or Reagent Problem (2910); Device Operates Differently Than Expected (2913)

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

Event Date 06/03/2015

Event Type  malfunction  

Event Description

The customer reported hgb (hemoglobin) failures at instrument startup on a coulter lh 500 hematology analyzer, and requested a service visit.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.There was no impact to patient results and controls.

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on 06/04/2015 and found incomplete hgb backgrounds on the instrument.The cause of the incomplete hgb was a dirty white blood cell (wbc) bath and aperture assembly.The bath and aperture assembly was replaced to resolve the incomplete hgb issue.The repairs were verified per established service procedures.(b)(6).

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: 4857157
• MDR Text Key: 5809246
• Report Number: 1061932-2015-01023
• 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: 06/03/2015

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: 06/03/2015
• Initial Date FDA Received: 06/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2005
• 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