MAUDE Adverse Event Report: ABBOTT GMBH PHOSPHORUS; PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS

Catalog Number 07D71-23

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Even though it was requested, additional patient details are not available.

Event Description

The customer observed falsely decreased phosphorus results generated on the architect c16000 processing module for multiple patient samples.The customer provided the following example results: (customer provided normal range 2.5-4.5 mg/dl) (b)(6) initial result = <0.7 mg/dl, repeat result on (c8000) = 2.1 mg/dl.(b)(6) initial result = 1.3 mg/dl, repeat result on (c8000) = 2.8 mg/dl.(b)(6) initial result = 1.2 mg/dl, repeat result on (c8000) = 2.7 mg/dl.(b)(6) initial result = 0.9 mg/dl, repeat result on (c8000) = 2.3 mg/dl.(b)(6) initial result = 1.7 mg/dl, repeat result on (c8000) = 3.2 mg/dl.(b)(6) initial result = <0.7 mg/dl, repeat result on (c8000) = 1.8 mg/dl.(b)(6) initial result = 1.7 mg/dl, repeat result on (c8000) = 3.3 mg/dl.(b)(6) initial result = 1.2 mg/dl, repeat result on (c8000) = 2.6 mg/dl.(b)(6) initial result = 1.6 mg/dl, repeat result on (c8000) = 3.0 mg/dl.(b)(6) initial result = 0.8 mg/dl, repeat result on (c8000) = 2.1 mg/dl.The customer reported an unknown number of patients were provided an unspecified treatment based on results and is not aware of any adverse effect on the patients.The results were then repeated on the architect c8000 and the customer believes the architect c8000 results are correct.Additional information was requested; however, no further information was provided at this time.No further impact to patient management was reported.

Manufacturer Narrative

Additional information in section b5 and updated information in section d4 primary udi number.The complaint investigation for false depressed phosphorus results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Data and information provided by the customer was reviewed and support the complaint issue.A ticket search by product lot did not identify an increase in complaint activity.Trending review determined there were no related trends identified.Labeling was reviewed and found to adequately address the issue under review.The device history record review did not identify any nonconformances or deviations associated with the likely cause lot number and complaint issue.Based on the investigation, no systemic issue or deficiency of the phosphorus assay for lot number 92386un23 was identified.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely decreased phosphorus results generated on the architect c16000 processing module for multiple patient samples.The customer provided the following example results: (customer provided normal range 2.5-4.5 mg/dl).Sample 1 initial result = <0.7 mg/dl, repeat result on (c8000) = 2.1 mg/dl.Sample 2 initial result = 1.3 mg/dl, repeat result on (c8000) = 2.8 mg/dl.Sample 3 initial result = 1.2 mg/dl, repeat result on (c8000) = 2.7 mg/dl.Sample 4 initial result = 0.9 mg/dl, repeat result on (c8000) = 2.3 mg/dl.Sample 5 initial result = 1.7 mg/dl, repeat result on (c8000) = 3.2 mg/dl.Sample 6 initial result = <0.7 mg/dl, repeat result on (c8000) = 1.8 mg/dl.Sample 7 initial result = 1.7 mg/dl, repeat result on (c8000) = 3.3 mg/dl.Sample 8 initial result = 1.2 mg/dl, repeat result on (c8000) = 2.6 mg/dl.Sample 9 initial result = 1.6 mg/dl, repeat result on (c8000) = 3.0 mg/dl.Sample 10 initial result = 0.8 mg/dl, repeat result on (c8000) = 2.1 mg/dl.The customer reported an unknown number of patients were provided an unspecified treatment based on results and is not aware of any adverse effect on the patients.The results were then repeated on the architect c8000 and the customer believes the architect c8000 results are correct.Additional information was requested; however, no further information was provided at this time.No further impact to patient management was reported.Additional information provided by the customer.The serial of the architect c8000 processing module used for repeat measurement was (b)(6).No further impact to patient management was reported.

• Brand Name: PHOSPHORUS
• Type of Device: PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18694258
• MDR Text Key: 335196670
• Report Number: 3002809144-2024-00036
• Device Sequence Number: 1
• Product Code: CEO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 07D71-23
• Device Lot Number: 92386UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, (B)(6).; ARC C16K PRC MOD, 03L77-01, (B)(6).
• Patient Outcome(s): Other