MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIXSPEC¿ CALIBRATOR KIT; NEPHELOMETER, FOR CLINICAL USE

Model Number	440911
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd phoenixspec¿ calibrator kit atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "evidence of reading out of range of new phoenix spec calibration kit 0.25 mf standard tube.Shows higher than normal reading (0.29 mf).Lot 1004886 f, expiration: 2021-11-06.".
Event or Problem Description
It was reported that while using bd phoenixspec¿ calibrator kit atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " evidence of reading out of range of new phoenix spec calibration kit 0.25 mf standard tube.Shows higher than normal reading (0.29 mf).Lot 1004886 f expiration 2021-11-06.".
Additional Manufacturer Narrative
H6: investigation summary an incorrect reading was reported when using a kit phoenixspec calibrator (p/n 440911, batch 1004886).The customer reported that the 0.25 mcf tube in the kit was reading 0.29 mcf.The specification for this tube is 0.24 - 0.28 mcf.The customer advised bd that the tube was not creating an error when calibrating their phoenixspec nephelometer, and no impact on sample preparation was reported as a result of this incorrect reading.The customer discovered the reading when performing qc verification on their phoenix ap instrument.The customer did not advise what the tube was reading on their nephelometer.Bd provided a replacement nephelometer, but this did not resolve the issue with the calibrator kit.The root cause is unknown.As no calibration failure was reported and it is not known if the source of the incorrect reading was the phoenix ap instrument, this is an unconfirmed failure of the calibrator kit.If more information is received, this complaint may be re-opened.Samples were not received by quality for investigation and thus, returned material investigation could not occur.If samples or further information is received at a later date, the complaint may be reopened.Review of the device history record consisted of a review of the inspection and packaging documentation for batch 1004886, as well as the certificate of conformance for this batch of calibrators.The 0.25 mcf calibrator (p/n 8011860, batch 20430049) inspection and manufacturing information were reviewed.The material was released in good condition.Service history review was conducted by investigating all complaints received by this customer location.No further complaints were identified related to the calibrator kit.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.

• Brand Name: BD PHOENIXSPEC¿ CALIBRATOR KIT
• Common Device Name: NEPHELOMETER, FOR CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11959044
• Report Number: 1119779-2021-00956
• Device Sequence Number: 19756071
• Product Code: JQX
• UDI-Device Identifier: 00382904409111
• UDI-Public: 00382904409111
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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
• Operator of Device: Other
• Device Expiration Date: 11/06/2021
• Device Model Number: 440911
• Device Catalogue Number: 440911
• Device Lot Number: 1004886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown