MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number 2P24-40

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2022

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

A patient came to an evening out of hours clinic on a weekend (b)(6) 2022 and was suspected of having septic arthritis.The customer stated that there were no architect analyzers operational at the clinic because the analyzers were down.The patient was referred to a&e (emergency room).The doctor did not draw any blood because he was informed that the analyzers were not working.The patient was sent home.The patient was admitted on monday (b)(6) 2022, very unwell and was given iv antibiotics.The customer is stated that the delay in antibiotics was due to ¿the doctor not taking blood¿ because the analyzers were not working.It unclear which lab result was delayed.Antibiotic treatment was delayed.

Manufacturer Narrative

Additional information received from the customer.The patient presented at a&e at 1700 on (b)(6) 2022.Bloods were only taken at this point.This sample sent to ari for testing.Second troponin blood sample taken at 1900 ¿ as per protocol.This was flown to ari on air ambulance with a patient transfer to ari (no commercial flights or ferry available at this time).However bloods lost in transit due to nurse error on ward where patient was transferred.No result provided for this patient.The service history from the incident that caused the analyzer to be down.The customer called to report the error 9077 unable to communicate to sample handler or processing module, error (37).Customer preformed several cycle powers but the module stay in disconnect.Customer confirmed all the leds are on, there is power on the instrument.Customer did not have analyzer available to process samples.An fse (field service engineer) was on site (b)(6) 2022.It appeared that they replaced the ethernet hub switch and ethernet cable over the weekend.After this the analyzers came back online.Engineer checked everything was connected correctly on monday morning.H3 other text : the evaluation is currently in process.

Manufacturer Narrative

The customer indicated that the instrument was unavailable at the time the patient was first admitted to (b)(6).Additional information regarding the status the instrument on the evening of 05nov2022, are as follows: (b)(6) ¿ 05nov2022.Customer called to report error 9077 unable to communicate to sample handler or processing module, error 37.Customer cycled power to the processing module several times, but the communication error continued.The customer requested service to address the issue the following monday, 07nov2022.Upon arrival on november 7, the abbott field service representative (fsr) discussed the issue with the customer and was informed that the customer had replaced the ethernet hub switch ¿over the weekend¿ and the issue was resolved at that time.The exact date and time the ethernet hub switch was replaced is unknown.The abbott fsr confirmed all ethernet connections were correct and the instrument was operational.The ticket notes state that (b)(6) hospital is in a remote location (shetlands), which can only be reached by plane which likely contributed to the service delays noted above.A review of the instrument logs associated with (b)(6) was performed by abbott technical operations and revealed that error code 9077 was generated on 05nov2022 at 11:10:23 and multiple times thereafter on the same day.The instrument log also revealed that the system generated patients results until 04nov2022 at 22:54:02.On 05nov2022, the system generated first control assay result at 18:28:58 indicating a period of inactivity between 04nov2022 and 05nov2022 that lasted approximately 20 hours.However, the system generated control and calibrator assay results on 05nov2022 from 18:28:58 and 19:23:44.This indicates that the system was operational with the end user ordering control and calibration assay runs via the user interface of the system control center (scc).Lastly, the system resumed generating patient results beginning on 06nov2022 at 00:02:19.These findings from the instrument log indicates that the system was not ¿non-operational¿ as stated in the report.Return testing was not performed as returns were not available.A review of historical data revealed no trends, systemic issues, or nonconformance associated with the issue described in this complaint (delayed results and/or error 9077 unable to communicate to sample handler or processing module).The investigation included a review of the complaint information, instrument logs, and relevant clinical management and determined the adverse event associated with delay in patient treatment was related to use error and not a malfunction of the architect c4000 processing module.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no deficiency was identified.

• Brand Name: ARCHITECT C4000
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15898887
• MDR Text Key: 304675726
• Report Number: 3016438761-2022-00564
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: 00380740003753
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2P24-40
• Device Catalogue Number: 02P24-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability